510(k) · Cleared

Recalled · Class II · 2022

Ussc Polyproplene Suture

K954808510(k) TraditionalCleared Feb 27, 1996131-day reviewClass II21 CFR 878.5010Recalls 1

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

United States Surgical, A Division of Tyco Healthc · GAW Suture, Nonabsorbable, Synthetic, Polypropylene

Cleared on Feb 27, 1996 after a 131-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 77 later devices descend from it. It has been recalled once.

Decided: Feb 27, 1996
Review: 131 days
Class: Class II
Product code: GAW
Recalls: 1
Predicates: 0

77 later devices descend from it, 2 citing it directly.

This deviceK954808 Ussc Polyproplene SutureUnited States Surgical, A Division of Tyco Healthc · 1996
Descendant · cites it directly · 76 of its ownK050947 Modification to: Modified Uss Polypropylene SutureUnited States Surgical, A Division of Tyco Healthc · 2005 · Recalled
Descendant · 2 generations on · 69 of its ownK063778 Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical · 2007 · Recalled
Descendant · 3 generations on · 29 of its ownK092533 Force Fiber Blue Ultra High Molecular Weight Polyethylene Non…Beere Precision Medical Instruments, Kmedic, Telef · 2009
Descendant · 3 generations on · 23 of its ownK070673 Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical SutureTeleflexmedical, Inc. · 2007
Descendant · 2 generations on · 15 of its ownK100006 HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro…Riverpoint Medical · 2010 · Recalled

Showing 5 of 77 descendants. See all descendants

Descendants cleared per year

2005high 10 (2015) · low 0 (2006)2026

Most influential descendants

Showing 5 of 77 · See all

K050947Modification to: Modified Uss Polypropylene SutureUnited States Surgical, A Division of Tyco Healthc · 2005 · cites it directly76descendants
K063778Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical · 2007 · 2 generations on69descendants
K092533Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable SuturesBeere Precision Medical Instruments, Kmedic, Telef · 2009 · 3 generations on29descendants
K070673Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical SutureTeleflexmedical, Inc. · 2007 · 3 generations on23descendants
K100006HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon…Riverpoint Medical · 2010 · 2 generations on15descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K954808	Ussc Polyproplene Suture	United States Surgical, A Division of Tyco Healthc	1996	—
+1	K050947	Modification to: Modified Uss Polypropylene Suture	United States Surgical, A Division of Tyco Healthc	2005	2
+2	K063778	Force Fiber Polyethylene Nonabsorbable Suture	Teleflex Medical	2007	1
+3	K092533	Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable Sutures	Beere Precision Medical Instruments, Kmedic, Telef	2009	—
+3	K070673	Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical Suture	Teleflexmedical, Inc.	2007	—
+2	K100006	HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene)…	Riverpoint Medical	2010	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2007	3	0
2009	3	0
2010	3	0
2012	3	0
2013	4	0
2014	4	0
2015	10	0
2016	4	0
2017	4	0
2018	6	0
2019	4	0
2020	4	0
2021	3	0
2022	1	0
2023	4	0
2024	6	0
2025	4	0
2026	6	0

FIG. 1 — Lineage of K954808, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 GAW? 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 GAW device

#1 K253572 STRATAFIX™ Spiral PRONOVA™ Unidirectional…score 14.4 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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? (77)

See all 77

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K050947	Modification to: Modified Uss Polypropylene Suture	United States Surgical, A Division of Tyco Healthc	2005	76
K133890	Aesculap Optilene Nonabsorbable Suture	Aesculap, Inc.	2014	5

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 2, 2022	Class II	Z-1179-2023	Packaging process control	Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K050947 (United States Surgical, A Division of Tyco Healthc, 2005) has gone furthest, with 76 descendants of its own.

How does its category compare?

All GAW devices

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

FDA decisions per year · GAW

1in 2024

2007high 3 (2012) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAW

80in 2018

2007high 252 (2015) · low 36 (2013)2026

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

Recalls per year · GAW

2so far in 2026, the most since 2007

2007high 2 (2026) · low 0 (2008)2026

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

Adverse event reports per year · GAW

2,545in 2025

2007high 2,545 (2025) · low 71 (2009)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	1	73
2008	0	—	0	75
2009	0	—	0	71
2010	2	—	0	85
2011	0	—	0	84
2012	3	86	0	194
2013	3	36	0	191
2014	2	—	0	437
2015	3	252	0	422
2016	1	—	0	440
2017	3	145	0	413
2018	3	80	0	685
2019	1	—	0	1,803
2020	2	—	0	1,493
2021	0	—	0	1,652
2022	2	—	0	1,563
2023	1	—	0	1,811
2024	1	—	0	2,348
2025	0	—	0	2,545
2026	1	—	2	—

https://510kreport.com/device/K954808 · printed Nov 4, 2026

Cite this page

510(k) Report. “K954808: Ussc Polyproplene Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954808

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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