American Hydro-Surgical Instruments, Inc.
Delray Beach, FL, US
American Hydro-Surgical Instruments, Inc. appears in FDA device records in Delray Beach, FL. FDA records list 18 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 18
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 18 510(k) clearances for American Hydro-Surgical Instruments, Inc. between 1993 and 1995. The busiest year on record is 1995, with 16. The most recent is 1995, with 16.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 16 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K953574 | NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER | HET | Substantially Equivalent | |
| K953481 | NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAGSQUEEZER | GCJ | Substantially Equivalent | |
| K952070 | NEZHAT-DORSEY ELECTROSURGICAL HAND CONTROL ATTACHMENTS, PENCIL-GRIP HANDLES & TRUMPET VALVE W/CUTTING & COAGULATION HANS | KNF | Substantially Equivalent | |
| K946380 | NEZHAT-DORSEY REUSABLE ASPIRATION-VAC PROBES WITH AND WITHOUT PUNCTURE CANNULA (HEREINAFTER REFERRED TO AS ASPIRATION-V) | HET | Substantially Equivalent | |
| K951300 | NEZHAT-DORSEY THERMAL RETENTION SYSTEM | LHC | Substantially Equivalent | |
| K950499 | NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS | KNF | Substantially Equivalent | |
| K951119 | NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM | GCX | Substantially Equivalent | |
| K952421 | NEZHAT-DORSEY REUSABLE UNIPOLAR COAGULATOR PROBE INSERTS | GCJ | Substantially Equivalent | |
| K951733 | NEXHAT-DORSEY PENCIL-GRIP TRUMPET VALVE WITH CUTTING AND COAGULATION HAND CONTROLS | GCJ | Substantially Equivalent | |
| K951732 | NEZHAT-DORESEY PENCIL-GRIP HANDLES | GEI | Substantially Equivalent | |
| K951731 | NEZHAT-DORESY ELECTROSURGICAL HAND CONTROL ATTACHMENTS | GEI | Substantially Equivalent | |
| K951086 | NEZHAT-DORSEY HYDRO-DISSECTION SYSTEM AND ACCESSORIES | GCJ | Substantially Equivalent | |
| K950507 | NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS | GEI | Substantially Equivalent | |
| K946089 | NEZHAT-DORSEY(TM) REUSABLE ASPIRATION-VAC(TM) PROBES WITH AND WITHOUT PUNCTURE CANNULA | GCJ | Substantially Equivalent | |
| K945694 | NEZHAT-DORSEY BIPOLAR ELECTROSURGICAL FORCEPS, SURFACE ELECTRODES, AND CORDS | GEI | Substantially Equivalent | |
| K945317 | NEZHAT-DORSEY (TM) ELECTROSHIELD(TM) PROBES AND ACCESSORIES | GEI | Substantially Equivalent | |
| K943927 | END-O-FOG ENDOSCOPIC FOG ELIMINATION SYSTEM | GCJ | Substantially Equivalent | |
| K930572 | NEZHAT-DORSEY HYDRO-DISSECTION SYSTEM II PUMP | GCJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain