The Anspach Effort, Inc.: FDA clearances and approvals
The Anspach Effort, Inc. has 60 FDA 510(k) clearances (first 1980, latest 2022), across 33 product codes in 7 review panels. Median 510(k) review time: 47 days. Since 2017 its median was 91 days, against 94 days for all cleared 510(k)s in the same product codes. openFDA lists 303 product recalls by a recalling firm named The Anspach Effort, Inc.
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, The Anspach Effort, Inc.'s cleared 510(k)s 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 company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of The Anspach Effort, Inc.'s product codes (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)
Frequently asked questions
How many FDA 510(k) clearances does The Anspach Effort, Inc. have?
The Anspach Effort, Inc. has 60 FDA 510(k) clearances (first 1980, latest 2022), across 33 product codes in 7 review panels.
How long does FDA take to clear The Anspach Effort, Inc.'s 510(k)s?
The median time from FDA receipt to decision across The Anspach Effort, Inc.'s cleared 510(k)s is 47 days. Since 2017: 91 days, versus 94 days for all cleared 510(k)s in the same product codes.
What devices does The Anspach Effort, Inc. make?
Its most frequent FDA product codes are HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered), 7); HRX (Arthroscope, 4); HSZ (Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment, 4).
Has The Anspach Effort, Inc. had device recalls?
openFDA lists 303 product recalls in 44 recall events by a recalling firm whose name matches The Anspach Effort, Inc; the most recent began 2022-12-07. Recall firm names are matched by name, so related entities filing under other names are not included.
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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.