Microline Pentax, Inc.
Wellesley, MA, US
Microline Pentax, Inc. appears in FDA device records in Wellesley, MA. FDA records list 12 510(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
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Microline Pentax, Inc. between 1988 and 2002. The busiest year on record is 1998, with 5. The most recent is 2002, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 2 |
| 1990 | 1 |
| 1993 | 1 |
| 1996 | 1 |
| 1997 | 1 |
| 1998 | 5 |
| 2002 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K013695 | MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10 | GCJ | Substantially Equivalent | |
| K982984 | ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS | GEI | Substantially Equivalent | |
| K981389 | DISPOSABLE RE-NEW FORCEPS | GEI | Substantially Equivalent | |
| K981188 | ELECTROSURGICAL CAUTERY PROBES | GEI | Substantially Equivalent | |
| K980758 | 3 MM SELEC-TIP LAPAROSCOPIC SCISSORS | GEI | Substantially Equivalent | |
| K974066 | RE-NEW FORCEPS LAPAROSCOPIC SURGICAL TIPS | GEI | Substantially Equivalent | |
| K970826 | SELECTA-TIP LAPAROSCOPIC SCISSORS | GEI | Substantially Equivalent | |
| K962119 | RE-NEW LAPAROSCOPIC INSTRUMENTS | GEI | Substantially Equivalent | |
| K932648 | QUICK SWITCH LAPAROSCOPIC INSTRUMENTS | GCJ | Substantially Equivalent | |
| K897093 | INTRAOCULAR MICROSCISSORS BY MEANS OF GAMMA RADIA. | HNF | Substantially Equivalent | |
| K881049 | BRADBURY INTRAOCULAR RETINAL KIT CAT #200 | HNR | Substantially Equivalent | |
| K880943 | MICROLINE CAT #100 | HQE | 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