510(k) Report

510(k) · Cleared

Cleared

Suture Nonabsorbable - Silk

K930826510(k) TraditionalCleared Jan 7, 1994324-day reviewClass II21 CFR 878.5030

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

Surgical Specialties, Inc. · GAP Suture, Nonabsorbable, Silk

Cleared on Jan 7, 1994 after a 324-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Jan 7, 1994
Review
324 days
Class
Class II
Product code
GAP
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared1990200020102020
  1. This deviceK930826 Suture Nonabsorbable - SilkSurgical Specialties, Inc. · 1994
  2. Descendant · cites it directly · 0 of its ownK071111 Non-Absorbable Silk SutureArrow Intl., Inc. · 2007

Most influential descendants

Showing 1 of 1 · See all
  • K071111Non-Absorbable Silk SutureArrow Intl., Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K930826Suture Nonabsorbable - SilkSurgical Specialties, Inc.1994—
+1K071111Non-Absorbable Silk SutureArrow Intl., Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
FIG. 1 — Lineage of K930826, 1994–2007Source: FDA 510(k) summaries, read by 510(k) Report · 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.

Planning a device in GAP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GAP device

  1. #1 K222944 SafePath Sulturing System-Silk Suture…score 9.7 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K071111Non-Absorbable Silk SutureArrow Intl., Inc.20070

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.

What does this lineage say?

  • Of its descendants, K071111 (Arrow Intl., Inc., 2007) has gone furthest, with 0 descendants of its own.

How does its category compare?

All GAP devices

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

FDA decisions per year · GAP

3in 2024

2007: 12008: 12016: 22017: 12018: 12023: 12024: 3
2007high 3 (2024) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAP

193in 2024

2024: 193 days median
2007high 193 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GAP

1in 2023

2011: 212014: 12018: 12023: 1
2007high 21 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GAP

478in 2025

2007: 72008: 212009: 122010: 242011: 62012: 82013: 32014: 152015: 252016: 542017: 552018: 3402019: 3332020: 4262021: 4372022: 4192023: 4042024: 4552025: 478
2007high 478 (2025) · low 3 (2013)2025

MAUDE reports naming product code GAP, 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
20071—07
20081—021
20090—012
20100—024
20110—216
20120—08
20130—03
20140—115
20150—025
20162—054
20171—055
20181—1340
20190—0333
20200—0426
20210—0437
20220—0419
20231—1404
202431930455
20250—0478
20260—0—

More from Surgical Specialties, Inc.

9 FDA decisions under this applicant name. See the company

  • K932038Suture Nonabsorbable- Silk, PolyesterSurgical Specialties, Inc. · 1994
  • K930825Suture Nonabsorbable-Nylon,Silk,Polyester,StainlesSurgical Specialties, Inc. · 19941 recall
  • K932037Suture Absorbable- GutSurgical Specialties, Inc. · 1994
  • K874219S3 Medicated GauzeSurgical Specialties, Inc. · 1987
  • K861445S1 Cavity PackingSurgical Specialties, Inc. · 1986

Recent decisions in GAP

The GAP category page

  • K241486Sofsilk™ Coated Braided Silk SutureCovidien · 2024
  • K222944SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing…Safepath Medical, Inc. · 2024
  • K232355Non absorbable Surgical Silk SutureShandong Haidike Medical Product Co., Ltd. · 2024
  • K221767Surgical Sutures with or without NeedleHuaian Seamen Medical Technology Co., Ltd. · 2023
  • K180701SafePath Suturing SystemSafepath Medical, Inc. · 2018

https://510kreport.com/device/K930826 · printed Nov 6, 2026

Cite this page

510(k) Report. “K930826: Suture Nonabsorbable - Silk.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K930826

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