Wallach Surgical Devices, Inc.: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Wallach Surgical Devices, Inc.” (first 1981, latest 2002), across 14 product codes in 6 review panels. Median 510(k) review time under this name: 98 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under CooperCompanies, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEH | Unit, Cryosurgical, Accessories | 5 | 5 |
| HGI | Electrocautery, Gynecologic (And Accessories) | 5 | 5 |
| HEX | Colposcope (And Colpomicroscope) | 4 | 4 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 3 | 3 |
| EKZ | Unit, Electrosurgical, And Accessories, Dental | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| GXH | Device, Surgical, Cryogenic | 1 | 1 |
| HEE | Set, Anesthesia, Paracervical | 1 | 1 |
| HFF | Aspirator, Endometrial | 1 | 1 |
Plus 4 more product codes.
Review panels
- Obstetrics and Gynecology (14)
- General and Plastic Surgery (9)
- Dental (1)
- General Hospital (1)
- Neurology (1)
- Radiology (1)
Most recent Wallach Surgical Devices, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K021224 | ENDOCERVICAL BLOCK NEEDLE | HEE | 2002-07-12 | 86 |
| K020711 | WALLACH LOOP ELECTRODE | GEI | 2002-06-03 | 90 |
| K000768 | WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR | EKZ | 2000-04-11 | 33 |
| K992736 | WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM | HIB | 1999-09-29 | 47 |
| K991669 | PMS 750 FINGERSWITCH | GEI | 1999-08-12 | 90 |
| K983840 | WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED) | HGI | 1999-05-20 | 202 |
| K984306 | `THE INSEMINATOR' (PROPOSED) | MFD | 1999-03-01 | 89 |
| K983208 | WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR | GEI | 1999-02-22 | 161 |
| K963653 | WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM | HGI | 1997-06-11 | 272 |
| K963348 | WALLACH INTEGRATION UNIT | HGI | 1997-03-19 | 205 |
17 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2007-06-06.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Wallach Surgical Devices, Inc.?
FDA lists 27 510(k) clearances under the applicant name “Wallach Surgical Devices, Inc.” (first 1981, latest 2002), across 14 product codes in 6 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 Wallach Surgical Devices, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wallach Surgical Devices, Inc. is 98 days.
Which FDA product codes appear under Wallach Surgical Devices, Inc.?
The most frequent FDA product codes under this applicant name are GEH (Unit, Cryosurgical, Accessories, 5); HGI (Electrocautery, Gynecologic (And Accessories), 5); HEX (Colposcope (And Colpomicroscope), 4).
Next steps
- See all 27 Wallach Surgical Devices, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEH, Wallach Surgical Devices, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.