American Hydro-Surgical Instruments, Inc.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “American Hydro-Surgical Instruments, Inc.” (first 1993, latest 1995), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 72 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 | 7 | 7 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 5 | 5 |
| HET | Laparoscope, Gynecologic (And Accessories) | 2 | 2 |
| KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | 2 | 2 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 1 | 1 |
| LHC | Warmer, Irrigation Solution | 1 | 1 |
Review panels
Most recent American Hydro-Surgical Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K953574 | NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER | HET | 1995-09-29 | 60 |
| K953481 | NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAGSQUEEZER | GCJ | 1995-08-16 | 23 |
| K952070 | NEZHAT-DORSEY ELECTROSURGICAL HAND CONTROL ATTACHMENTS, PENCIL-GRIP HANDLES & TRUMPET VALVE W/CUTTING & COAGULATION HANS | KNF | 1995-07-26 | 85 |
| K946380 | NEZHAT-DORSEY REUSABLE ASPIRATION-VAC PROBES WITH AND WITHOUT PUNCTURE CANNULA (HEREINAFTER REFERRED TO AS ASPIRATION-V) | HET | 1995-07-06 | 205 |
| K951300 | NEZHAT-DORSEY THERMAL RETENTION SYSTEM | LHC | 1995-06-20 | 90 |
| K950499 | NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS | KNF | 1995-06-16 | 130 |
| K951119 | NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM | GCX | 1995-06-13 | 95 |
| K952421 | NEZHAT-DORSEY REUSABLE UNIPOLAR COAGULATOR PROBE INSERTS | GCJ | 1995-06-08 | 16 |
| K951733 | NEXHAT-DORSEY PENCIL-GRIP TRUMPET VALVE WITH CUTTING AND COAGULATION HAND CONTROLS | GCJ | 1995-05-31 | 47 |
| K951732 | NEZHAT-DORESEY PENCIL-GRIP HANDLES | GEI | 1995-05-24 | 40 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named American Hydro-Surgical Instruments, Inc..
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.
- American Dade (149 510(k)s)
- American Edwards Laboratories (89 510(k)s)
- American Medical Systems, Inc. (82 510(k)s)
- American Bioproducts Co. (79 510(k)s)
- American Monitor Corp. (73 510(k)s)
- American Pharmaseal Div. Ahsc (64 510(k)s)
- American Bentley (59 510(k)s)
- American Hospital Supply Corp. (56 510(k)s)
- American Research Products Co. (56 510(k)s)
- American Orthodontics (46 510(k)s)
- American Diagnostic Corp. (39 510(k)s)
- American Laboratory Supply, Inc. (36 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under American Hydro-Surgical Instruments, Inc.?
FDA lists 18 510(k) clearances under the applicant name “American Hydro-Surgical Instruments, Inc.” (first 1993, latest 1995), across 6 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 American Hydro-Surgical Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name American Hydro-Surgical Instruments, Inc. is 72 days.
Which FDA product codes appear under American Hydro-Surgical Instruments, Inc.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 7); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 5); HET (Laparoscope, Gynecologic (And Accessories), 2).
Next steps
- See all 18 American Hydro-Surgical Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, American Hydro-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.