INSORB ABSORBABLE STAPLES, MODEL SP-B20— 510(k) K024117

Clearance details

Applicant

Incisive Surgical, Inc.

Product code

Code GDW

Device class

Class 2

Regulation

21 CFR 878.4750

Advisory panel

General, Plastic Surgery

Date received

2002-12-13

Decision date

2003-04-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Minnetonka, MN, US

• K260196 — ETHICON Circular Stapler (CDH21mm) +7 more2026-05-11
• K253657 — Tri-staple 2.0 Reloads +3 more2026-04-10
• K252739 — ETHICON 4000 45mm Compact Stapler (EC3DT45C) +6 more2025-12-17
• K250835 — ETHICON 4000 60mm Compact Stapler (EC3D60C) +6 more2025-05-14
• K243276 — ECHELON LINEAR Stapler 30mm Stapler (GTX30) +8 more2025-02-25

• K120373 — INSORB ABSORBALBE STAPLE2012-03-16
• K090159 — INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES2009-02-06
• K061784 — INSORB ABSORBABLE STAPLE, MODEL 10202006-07-26
• K033602 — INSORB ABSORBABLE STAPLE, MODEL SP-B202003-12-16

Death

450

Injury

12,684

Malfunction

68,730

Other

6

Total

81,870

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1545-2015 — Insorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable copolymer which is a synthetic polyester derived from lactic and glycolic acids. It is chemically similar to other surgical glycolide/lactide-based copolymers. Polyglycolic/polylactic acid copolymers degrade in vivo by hydrolysis to glycolic acid and lactic acid which are then absorbed and metabolized by the body.Class II·Terminated·Incisive Surgical Inc·20150319

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K024117.