510(k) Report

FDA applicant

Incisive Surgical, Inc.

Plymouth, MN5 decisions2003–20122 recalls

FDA records 5 decisions for Incisive Surgical, Inc. (Plymouth, MN) from 2003 to 2012: 5 510(k) clearances. All are in product code GDW (Staple, Implantable). Its devices cite 7 predicates, 2 of them its own earlier devices. 2 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 Incisive Surgical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2009: 12012: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2018

2015: 12018: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Incisive Surgical, 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?

  • GDWStaple, Implantable5decisions

Whose devices does it build on?

Its devices cite 7 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 2 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.

  • K024117Insorb Absorbable Staples, Model SP-B20Incisive Surgical, Inc. · 20033cite it
  • K033602Insorb Absorbable Staple, Model SP-B20Incisive Surgical, Inc. · 20032cite it
  • K090159Insorb Absorbable Staple, Model 1020, 1025, and Other Product FamiliesIncisive Surgical, Inc. · 20092cite it
  • K061784Insorb Absorbable Staple, Model 1020Incisive Surgical, Inc. · 20061cites it
  • K120373Insorb Absorbalbe StapleIncisive Surgical, Inc. · 20121cites it

What has FDA decided for it lately?

  • K120373Insorb Absorbalbe StapleIncisive Surgical, Inc. · 20122 recalls
  • K090159Insorb Absorbable Staple, Model 1020, 1025, and Other Product FamiliesIncisive Surgical, Inc. · 20091 recall
  • K061784Insorb Absorbable Staple, Model 1020Incisive Surgical, Inc. · 20061 recall
  • K033602Insorb Absorbable Staple, Model SP-B20Incisive Surgical, Inc. · 20031 recall
  • K024117Insorb Absorbable Staples, Model SP-B20Incisive Surgical, Inc. · 20031 recall

All 5 as Incisive Surgical, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K120373Insorb Subcuticular Skin Stapler, Ref 2030Aug 29, 2018Class II
  • K024117Insorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable copolymer…Mar 19, 2015Class II

Other applicant names beginning “Incisive”

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

Incisive Technologies, Inc. 4Incisive, LLC 3Incisive, Inc. (Formerly Named Incisive, LLC) 1