INSORB ABSORBABLE STAPLE, MODEL SP-B20— 510(k) K033602

Name: FDA 510(k) clearance K033602
Creator: U.S. Food and Drug Administration
Published: 2003-12-16

Substantially Equivalent

Incisive Surgical, Inc.

FDA 510(k) clearance K033602 for INSORB ABSORBABLE STAPLE, MODEL SP-B20, Substantially Equivalent on 2003-12-16. Applicant: Incisive Surgical, Inc.. Device class: 2.

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: 2003-11-14
Decision date: 2003-12-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GDW

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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

More clearances from Incisive Surgical, Inc.

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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
K024117 — INSORB ABSORBABLE STAPLES, MODEL SP-B202003-04-22

Adverse events under product code GDW

product code GDW

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 →

Recalls naming K033602

K-number listed on FDA's recall record

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 K033602.

Data sourced from openFDA. This site is unofficial and independent of the FDA.