J. Jamner Surgical Instruments, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “J. Jamner Surgical Instruments, Inc.” (first 1977, latest 2008), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 127 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 | 3 | 3 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| DWS | Instruments, Surgical, Cardiovascular | 1 | 1 |
| GEN | Forceps, General & Plastic Surgery | 1 | 1 |
| HDC | Tenaculum, Uterine | 1 | 1 |
| KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | 1 | 1 |
Review panels
- General and Plastic Surgery (6)
- Ear, Nose and Throat (2)
- Obstetrics and Gynecology (2)
- Cardiovascular (1)
Most recent J. Jamner Surgical Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K082349 | JARIT HULKA UTERINE TENACULUM FORCEPS | HDC | 2008-11-21 | 98 |
| K944670 | JARIT RECOMMENDED SINUS INSTRUMENTS | EOB | 1995-02-02 | 133 |
| K944870 | JARIT ENDOSCOPES, MODELS 600-600; 600-630; 600-650; AND 600-680 | GCJ | 1994-11-02 | 41 |
| K941565 | JARIT RECOMMENDED SINUS INSTRUMENTS | EOB | 1994-05-16 | 45 |
| K932456 | JARIT SURGICAL INSTRUMENTS | KNF | 1994-04-21 | 335 |
| K933728 | JARIT SURGICAL INSTRUMENTS: CATALOG 615-330, 615-331, 615-334, 615-335, 615-338, 615-339 | GEI | 1994-02-23 | 205 |
| K931928 | JARIT SURGICAL INSTRUMENTS | GCJ | 1993-11-10 | 208 |
| K931959 | JARIT SURGICAL INSTRUMENTS | GEI | 1993-10-05 | 167 |
| K931878 | JARIT ENDOSCOPES, 600-600; 600-630; 600-650; 680 | GCJ | 1993-08-19 | 127 |
| K771625 | LEININGEO AORTIC PUNCH #310-395 & 397 | DWS | 1977-09-12 | 18 |
1 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2006-11-14.
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 J. Jamner Surgical Instruments, Inc.?
FDA lists 11 510(k) clearances under the applicant name “J. Jamner Surgical Instruments, Inc.” (first 1977, latest 2008), across 7 product codes in 4 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 J. Jamner Surgical Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name J. Jamner Surgical Instruments, Inc. is 127 days.
Which FDA product codes appear under J. Jamner Surgical Instruments, Inc.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 3); EOB (Nasopharyngoscope (Flexible Or Rigid), 2); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 2).
Next steps
- See all 11 J. Jamner Surgical Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, J. Jamner Surgical Instruments, 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.