Apple Medical Corp.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Apple Medical Corp.” (first 1994, latest 2006), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 82 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| HGI | Electrocautery, Gynecologic (And Accessories) | 2 | 2 |
| FCS | Light, Catheter, Fiberoptic, Glass, Ureteral | 1 | 1 |
| FHA | Clamp, Penile | 1 | 1 |
| FHO | Pneumoperitoneum Needle | 1 | 1 |
| GAD | Retractor | 1 | 1 |
| HHK | Curette, Suction, Endometrial (And Accessories) | 1 | 1 |
Review panels
Most recent Apple Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K061651 | FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158 | HGI | 2006-10-20 | 129 |
| K050256 | APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR | GAD | 2005-04-26 | 82 |
| K041131 | APPLE MEDICAL OB MOBIUS ELASTIC RETRACTOR | GCJ | 2004-05-13 | 13 |
| K014005 | APPLE MEDICAL MOBIUS ELASTIC RETRACTOR | GCJ | 2002-02-15 | 72 |
| K000026 | APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER | HHK | 2000-03-31 | 86 |
| K970788 | PNEUMO-MATIC INSUFFLATION NEEDLE | FHO | 1997-03-27 | 23 |
| K961460 | LWEET CONE BIOPSY INSTRUMENT | HGI | 1996-11-19 | 217 |
| K952841 | THE ASSISTANT | FHA | 1995-08-18 | 58 |
| K941506 | URETERAL ILLUMINATOR | FCS | 1994-10-05 | 190 |
Recalls
8 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2006-03-10.
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.
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.
- Apple, Inc. (9 510(k)s)
- Apple Diagnostic Products (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Apple Medical Corp.?
FDA lists 9 510(k) clearances under the applicant name “Apple Medical Corp.” (first 1994, latest 2006), across 7 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 Apple Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Apple Medical Corp. is 82 days.
Which FDA product codes appear under Apple Medical Corp.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 2); HGI (Electrocautery, Gynecologic (And Accessories), 2); FCS (Light, Catheter, Fiberoptic, Glass, Ureteral, 1).
Next steps
- See all 9 Apple Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Apple Medical Corp.'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.