New England Surgical Instrument Corp.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “New England Surgical Instrument Corp.” (first 1981, latest 1989), across 13 product codes in 4 review panels. Median 510(k) review time under this name: 31 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 6 | 6 |
| EMM | Chisel, Osteotome, Surgical | 1 | 1 |
| FFA | Tube, Drainage, Suprapubic | 1 | 1 |
| GEN | Forceps, General & Plastic Surgery | 1 | 1 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | 1 | 1 |
| GFF | Bur, Surgical, General & Plastic Surgery | 1 | 1 |
| HAM | Apparatus, Electrosurgical | 1 | 1 |
| HBO | Clip, Scalp | 1 | 1 |
| HCE | Clamp, Carotid Artery | 1 | 1 |
| HTD | Forceps | 1 | 1 |
Plus 3 more product codes.
Review panels
Most recent New England Surgical Instrument Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K895337 | ELECTROSURGICAL COAGULATION SUCTION TUBE | HAM | 1989-09-15 | 16 |
| K895331 | ELECTROSURGICAL ELECTRODE | JOS | 1989-09-15 | 16 |
| K883963 | RANEY AND LEROY-RANEY SCALP CLIP | HBO | 1988-10-07 | 17 |
| K883396 | HANDSWITCHING MONOPOLAR PENCIL | GEI | 1988-09-13 | 33 |
| K880863 | BIPOLAR MICRO COAGULATOR MODELS 25-1000 & 25-1200 | GEI | 1988-04-19 | 49 |
| K880859 | SURGICAL BURS | GFF | 1988-03-21 | 20 |
| K872271 | VARIOUS SIZES & STYLES OF MONOPOLAR FORCEPS | GEN | 1987-06-26 | 14 |
| K872209 | ARTHROPLASTY MALLET | HXL | 1987-06-23 | 14 |
| K864770 | SUCTION TUBE | FFA | 1987-02-24 | 81 |
| K864775 | CHISEL (OSTEOTOME, GOUGE, ETC.) | EMM | 1987-02-12 | 69 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named New England Surgical Instrument Corp..
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 New England Surgical Instrument Corp.?
FDA lists 18 510(k) clearances under the applicant name “New England Surgical Instrument Corp.” (first 1981, latest 1989), across 13 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 New England Surgical Instrument Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name New England Surgical Instrument Corp. is 31 days.
Which FDA product codes appear under New England Surgical Instrument Corp.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 6); EMM (Chisel, Osteotome, Surgical, 1); FFA (Tube, Drainage, Suprapubic, 1).
Next steps
- See all 18 New England Surgical Instrument Corp. clearances with predicates and recalls
- Run predicate analysis for product code GEI, New England Surgical Instrument 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.