# Microline Pentax, Inc.

- Location (FDA's records): Wellesley, MA
- FDA decisions: 12 (1988–2002): 12 510(k) clearances
- Product codes: GEI (7), GCJ (2), HNR (1), HNF (1), HQE (1)
- Predicates its devices cite: 9 (7 its own); citations of its devices by later devices: 21 (7 its own)
- Recalls linked to its devices: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Olsen Electrosurgical, Inc.: 1 (https://510kreport.com/company/olsen-electrosurgical)
- Richard Wolf Medical Instruments Corp.: 1 (https://510kreport.com/company/richard-wolf-medical-instruments)

## Firms that cite its devices most
- Microline Surgical, Inc.: 3 (https://510kreport.com/company/microline-surgical)
- Aesculap, Inc.: 2 (https://510kreport.com/company/aesculap)
- Vectec: 2 (https://510kreport.com/company/vectec)
- Agency For Medical Innovations GmbH: 1 (https://510kreport.com/company/agency-for-medical-innovations)
- Snowden-Pencer: 1 (https://510kreport.com/company/snowden-pencer)
- Getsch+Hiller Medizintechnik GmbH: 1 (https://510kreport.com/company/getsch-hiller-medizintechnik)
- Applied Medical Resources: 1 (https://510kreport.com/company/applied-medical-resources)
- Taiwan Surgical Corporation: 1 (https://510kreport.com/company/taiwan-surgical)

## Its most-cited devices
- K962119: RE-New Laparoscopic Instruments (1996), cited by 11
- K974066: RE-New Forceps Laparoscopic Surgical Tips (1998), cited by 2
- K980758: 3 MM Selec-Tip Laparoscopic Scissors (1998), cited by 2
- K970826: Selecta-Tip Laparoscopic Scissors (1997), cited by 2
- K932648: Quick Switch Laparoscopic Instruments (1993), cited by 1
- K981188: Electrosurgical Cautery Probes (1998), cited by 1

## Recent decisions
- K013695: Microline Inc. Reusable Laparoscopic Clip Applier with Implantable Titanium Clips, Model M/L-10 (Jan 8, 2002)
- K982984: Accushear Laparoscopic Surgical Instruments (Oct 21, 1998)
- K981389: Disposable RE-New Forceps (May 29, 1998)
- K981188: Electrosurgical Cautery Probes (May 20, 1998)
- K980758: 3 MM Selec-Tip Laparoscopic Scissors (Mar 27, 1998)
- K974066: RE-New Forceps Laparoscopic Surgical Tips (Jan 22, 1998)
- K970826: Selecta-Tip Laparoscopic Scissors (Mar 28, 1997)
- K962119: RE-New Laparoscopic Instruments (Aug 9, 1996)

Source page: https://510kreport.com/company/microline-pentax