Access Surgical Intl., Inc.
Bedminster, NJ, US
Access Surgical Intl., Inc. appears in FDA device records in Bedminster, NJ. FDA records list 9 510(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
- 9
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 9 510(k) clearances for Access Surgical Intl., Inc. between 1992 and 1995. The busiest year on record is 1992, with 3. The most recent is 1995, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 3 |
| 1993 | 1 |
| 1994 | 2 |
| 1995 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K954536 | BLADE, SCALPEL & BLADE, HANDEL | OCZ | Substantially Equivalent | |
| K953376 | ACCESS POINT | GCJ | Substantially Equivalent | |
| K945545 | ACCESS SURGICAL INT'L THORACIC ENDOSCOPIC SURGICAL INSTRUMENTS | GCJ | Substantially Equivalent | |
| K944974 | ACCESS POINT | GCJ | Substantially Equivalent | |
| K940587 | FLEX-I-PORT | GCJ | Substantially Equivalent | |
| K933192 | ACCESS SURGICAL INT'L INC. ENDOSCOPIC SURG. INST. | GCJ | Substantially Equivalent | |
| K922424 | ACCESS SURGICAL INT'L ENDOSCOPIC SURGICAL INSTRUM. | GCJ | Substantially Equivalent | |
| K922423 | ACCESS SURGICAL BIPOLAR ENDOSCOPIC SURG. INSTRUM. | GEI | Substantially Equivalent | |
| K922425 | ACCESS SURGICAL MONOPOLAR ENDOSCOPIC SURG. INSTRUM | GEI | 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