The Anspach Effort, Inc.: FDA filings under this applicant name
FDA lists 60 510(k) clearances under the applicant name “The Anspach Effort, Inc.” (first 1980, latest 2022), across 33 product codes in 7 review panels. Median 510(k) review time under this name: 47 days. Since 2017 the median was 91 days, against 94 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 259 |
| 2014 | 1 | 46 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 77 |
| 2019 | 1 | 211 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 91 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name The Anspach Effort, Inc. took a median 91 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 94 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 7 | 7 |
| HRX | Arthroscope | 4 | 4 |
| HSZ | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | 4 | 4 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 4 | 4 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 3 | 3 |
| GEY | Motor, Surgical Instrument, Ac-Powered | 3 | 3 |
| HBB | Motor, Drill, Pneumatic | 3 | 3 |
| HBC | Motor, Drill, Electric | 3 | 3 |
| FWZ | Operating Room Accessories Table Tray | 2 | 2 |
| GAD | Retractor | 2 | 2 |
Plus 23 more product codes.
Review panels
- Orthopedic (18)
- General and Plastic Surgery (17)
- Neurology (16)
- Ear, Nose and Throat (3)
- General Hospital (2)
- Anesthesiology (1)
- Cardiovascular (1)
Most recent The Anspach Effort, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220485 | Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) | HBC | 2022-05-19 | 91 |
| K183545 | Anspach Helix Dissection Tools | HBE | 2019-07-19 | 211 |
| K180063 | OCM-G1 Attachment | ERL | 2018-03-27 | 77 |
| K133604 | ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS | HBC | 2014-01-10 | 46 |
| K131053 | ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM | ERL | 2013-12-31 | 259 |
| K113476 | ANSPACH DISSECTION TOOLS | HBE | 2011-12-16 | 24 |
| K082637 | CRANIAL PERFORATOR | HBF | 2008-12-22 | 103 |
| K080802 | EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL | HBE | 2008-04-30 | 40 |
| K061297 | ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM | HBB | 2007-01-26 | 262 |
| K063688 | SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE | HWE | 2007-01-16 | 35 |
50 earlier clearances. See the full list in Caduvo.
Recalls
303 product recalls in 44 recall events; 9 initiated in the last five years. Most recent: 2022-12-07.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under The Anspach Effort, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Anspach Mfg., Inc. (3 510(k)s)
- Anspach Fixation Systems (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under The Anspach Effort, Inc.?
FDA lists 60 510(k) clearances under the applicant name “The Anspach Effort, Inc.” (first 1980, latest 2022), across 33 product codes in 7 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by The Anspach Effort, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name The Anspach Effort, Inc. is 47 days. Since 2017: 91 days, versus 94 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under The Anspach Effort, Inc.?
The most frequent FDA product codes under this applicant name are HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered), 7); HRX (Arthroscope, 4); HSZ (Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment, 4).
Next steps
- See all 60 The Anspach Effort, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HBE, The Anspach Effort, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.