510(k) Report

510(k) · Cleared

Cleared

Sharpoint Stainless Steel Suture

K863034510(k) TraditionalCleared Sep 30, 198650-day reviewClass II21 CFR 878.4495

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Chathamborough Research Group, Inc. · GAO Suture, Nonabsorbable

Cleared on Sep 30, 1986 after a 50-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Sep 30, 1986
Review
50 days
Class
Class II
Product code
GAO
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K863034Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All GAO devices

GAO Suture, Nonabsorbable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GAO

FDA has decided no GAO device since 2007.

Median 510(k) review, days · GAO

Too few GAO 510(k)s in any year since 2007 to give a median.

Recalls per year · GAO

No recall names GAO since 2007.

Adverse event reports per year · GAO

26in 2025

2007: 222008: 162009: 172010: 172011: 502012: 282013: 442014: 62015: 62016: 72017: 42018: 62019: 142020: 32021: 82022: 132023: 52024: 122025: 26
2007high 50 (2011) · low 3 (2020)2025

MAUDE reports naming product code GAO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—022
20080—016
20090—017
20100—017
20110—050
20120—028
20130—044
20140—06
20150—06
20160—07
20170—04
20180—06
20190—014
20200—03
20210—08
20220—013
20230—05
20240—012
20250—026
20260—0—

More from Chathamborough Research Group, Inc.

4 FDA decisions under this applicant name. See the company

  • K915676Splatter ShieldChathamborough Research Group, Inc. · 1992
  • K904906Sharpoint Polypropylene Nonabsorb Surg Sutures UspChathamborough Research Group, Inc. · 19901 recall
  • K902309Parker Micropump Model 2100Chathamborough Research Group, Inc. · 1990

Recent decisions in GAO

The GAO category page

  • K932513Labeling for Myo/Wire II Sternotomy SuturesAlto Development Corp. · 1994
  • N12815/S023Mersilene*Polyester SutureETHICON, Inc. · 1988
  • N12815/S022Mersilene*Polyester SutureETHICON, Inc. · 1987
  • K872532Auto Suture Stainless Steel Sutures*United States Surgical, A Division of Tyco Healthc · 1987
  • N12815/S021Mersilene*Polyester SutureETHICON, Inc. · 1987

https://510kreport.com/device/K863034 · printed Nov 6, 2026

Cite this page

510(k) Report. “K863034: Sharpoint Stainless Steel Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K863034

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026