Inamed Development Co.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Inamed Development Co.” (first 1989, latest 1994), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 102 days. 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 | 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 |
|---|---|---|---|
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 3 | 3 |
| FFP | Dilator, Rectal | 1 | 1 |
| FZW | Expander, Surgical, Skin Graft | 1 | 1 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 1 | 1 |
| KGO | Surgeon'S Gloves | 1 | 1 |
Review panels
Most recent Inamed Development Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K931548 | INAMED DEVELOPMENT ASPIRATION TIP | GCX | 1994-01-10 | 287 |
| K904265 | INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER | FZW | 1991-03-06 | 169 |
| K901764 | INAMED CONVERTIBLE DRAIN SYSTEM | GCY | 1990-05-07 | 19 |
| K901742 | INAMED SMALL DRAIN SYSTEM | GCY | 1990-05-07 | 20 |
| K894618 | INAMED RHEMO-D (TM) DILATOR | FFP | 1990-01-18 | 182 |
| K896491 | INAMED CLOSED-WOUND DRAIN SYSTEM | GCY | 1990-01-08 | 56 |
| K894073 | INAMED PRO-TEC SILICONE SURGICAL GLOVES | KGO | 1989-09-18 | 102 |
Recalls
openFDA lists no recalls under a recalling firm named Inamed Development Co..
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 Inamed Development Co.?
FDA lists 7 510(k) clearances under the applicant name “Inamed Development Co.” (first 1989, latest 1994), across 5 product codes in 3 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 Inamed Development Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Inamed Development Co. is 102 days.
Which FDA product codes appear under Inamed Development Co.?
The most frequent FDA product codes under this applicant name are GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered, 3); FFP (Dilator, Rectal, 1); FZW (Expander, Surgical, Skin Graft, 1).
Next steps
- See all 7 Inamed Development Co. clearances with predicates and recalls
- Run predicate analysis for product code GCY, Inamed Development Co.'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.