510(k) Report

FDA applicant

Microline Pentax, Inc.

Wellesley, MA12 decisions1988–20028 recalls

FDA records 12 decisions for Microline Pentax, Inc. (Wellesley, MA) from 1988 to 2002: 12 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 9 predicates, 7 of them its own earlier devices. 8 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Microline Pentax, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Microline Pentax, Inc. since 2007.

Recalls per year

3in 2017

2011: 22014: 32017: 3
2007high 3 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Microline Pentax, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Microline Pentax, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories7decisions
  • GCJLaparoscope, General & Plastic Surgery2decisions
  • HNRForceps, Ophthalmic1decision
  • HNFScissors, Ophthalmic1decision
  • HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered1decision

Whose devices does it build on?

Its devices cite 9 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 21 times; 7 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K962119RE-New Laparoscopic InstrumentsMicroline Pentax, Inc. · 199611cite it
  • K974066RE-New Forceps Laparoscopic Surgical TipsMicroline Pentax, Inc. · 19982cite it
  • K9807583 MM Selec-Tip Laparoscopic ScissorsMicroline Pentax, Inc. · 19982cite it
  • K970826Selecta-Tip Laparoscopic ScissorsMicroline Pentax, Inc. · 19972cite it
  • K932648Quick Switch Laparoscopic InstrumentsMicroline Pentax, Inc. · 19931cites it
  • K981188Electrosurgical Cautery ProbesMicroline Pentax, Inc. · 19981cites it

What has FDA decided for it lately?

  • K013695Microline Inc. Reusable Laparoscopic Clip Applier with Implantable Titanium Clips, Model M/L-10Microline Pentax, Inc. · 2002
  • K982984Accushear Laparoscopic Surgical InstrumentsMicroline Pentax, Inc. · 1998
  • K981389Disposable RE-New ForcepsMicroline Pentax, Inc. · 19986 recalls
  • K981188Electrosurgical Cautery ProbesMicroline Pentax, Inc. · 1998
  • K9807583 MM Selec-Tip Laparoscopic ScissorsMicroline Pentax, Inc. · 1998
  • K974066RE-New Forceps Laparoscopic Surgical TipsMicroline Pentax, Inc. · 19981 recall
  • K970826Selecta-Tip Laparoscopic ScissorsMicroline Pentax, Inc. · 1997
  • K962119RE-New Laparoscopic InstrumentsMicroline Pentax, Inc. · 19962 recalls

All 12 as Microline Pentax, Inc. →

What has been recalled?

8 recalls linked to its devices; the latest:

  • K962119ReNew Endocut Scissor Disposable Tip, Catalog Number: 3142, UDI: 00811099012115 The…Nov 1, 2017Class II
  • K981389ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811099011989…Nov 1, 2017Class II
  • K962119The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic…Jul 13, 2017Class II
  • K981389Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusable) Ref 3222May 12, 2014Class II
  • K981389Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips Ref 3221May 12, 2014Class II
  • K981389Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number…Apr 14, 2014Class II

Other applicant names beginning “Microline”

FDA records each applicant name separately; these may or may not be the same firm.

Microline Scientific 14Microline Surgical, Inc. 8