510(k) Report

510(k) · Cleared

Cleared

Pga Resorba, Pga Resoquick, Glycolon

K143584510(k) TraditionalCleared Nov 2, 2015319-day reviewClass II21 CFR 878.4493

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

Resorba Medical GmbH · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

Cleared on Nov 2, 2015 as substantially equivalent to K984374 (Samyang Corp., 1999) and 3 other predicates after a 319-day review. Its family tree reaches back 2 generations to 2002.

Decided
Nov 2, 2015
Review
319 days
Class
Class II
Product code
GAM
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K022269 (2002). 5 ancestors in all, the oldest K960653 (1996). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestor1999: 1 other ancestor1996: 1 other ancestorK022269 · Coated Vicryl* (Polyglactin 910) Suture · ETHICON, Inc. · 2002 · recalledK062366 · Optime, Sinusorb Pga · Peters Surgical · 200619952000200520102015
Other ancestors, by generation 1 generation back: 3 other ancestors K062366 · Optime, Sinusorb Pga · Peters Surgical · 2006K022269 · Coated Vicryl* (Polyglactin 910) Suture · ETHICON, Inc. · 2002 · recalled0
  1. Root · 2 generations backK022269 Coated Vicryl* (Polyglactin 910) SutureETHICON, Inc. · 2002 · Recalled
  2. 1 generation backK062366 Optime, Sinusorb PgaPeters Surgical · 2006
  3. This deviceK143584 Pga Resorba, Pga Resoquick, GlycolonResorba Medical GmbH · 2015
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K022269Coated Vicryl* (Polyglactin 910) SutureETHICON, Inc.20023
−1K062366Optime, Sinusorb PgaPeters Surgical2006—
0 (this device)K143584Pga Resorba, Pga Resoquick, GlycolonResorba Medical GmbH2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199910
200110
FIG. 1 — Lineage of K143584, 2002–2015Source: 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), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GAM? 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 GAM device

  1. #1 K252743 STRATAFIX™ Spiral PDS™ Plus Knotless Tissue…score 14.8 · 15 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? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K984374Surgisorb
Summary page 6
…f device device PGA Suture, absorbable, Absorbable 21 CFR GAM Il Surgisorb, RESORBA® synthetic, poly(glycolide/I- | §878.4493 Samyang polyglycolic acid lactide) surgical K984374 suture PGA Suture, absorbable, Absorbable 21 CFR GAM 1l Safil Quick, Resoquick synthetic, poly(glycolide/I- | §878.4493 Aesculap…
Samyang Corp.1999—
*K011372Aesculap, Inc. Safil Quick Synthetic Absorbable Surgical Suture
Summary page 6
…4374 suture PGA Suture, absorbable, Absorbable 21 CFR GAM 1l Safil Quick, Resoquick synthetic, poly(glycolide/I- | §878.4493 Aesculap polyglycolic acid lactide) surgical K011372 suture *Surgisorb, Samyang K984374 *Optime Peters Surgical K062366 GLYCOLON?® | Suture, absorbable, Absorbable 21 CFR GAM I Monoc…
Aesculap, Inc.2001—
*K062366Optime, Sinusorb Pga
Summary page 6
…Quick, Resoquick synthetic, poly(glycolide/I- | §878.4493 Aesculap polyglycolic acid lactide) surgical K011372 suture *Surgisorb, Samyang K984374 *Optime Peters Surgical K062366 GLYCOLON?® | Suture, absorbable, Absorbable 21 CFR GAM I Monocryl synthetic, poly(glycolide/I- | §878.4493 Ethicon polyglycolic a…
Peters Surgical2006—
*K960653Monocryl (Poliglecaprone 25) Suture, Dyed (Modified)
Summary page 6
…s Surgical K062366 GLYCOLON?® | Suture, absorbable, Absorbable 21 CFR GAM I Monocryl synthetic, poly(glycolide/I- | §878.4493 Ethicon polyglycolic acid lactide) surgical K960653 suture *Secondary predicates Absorbable sutures Traditional 510(k) Premarket Notification K143584 pg. 2 of 4…
ETHICON, Inc.19962

Also cleared against K984374: 6 other devices →

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.

What does this lineage say?

  • The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 9.1 years on median.
  • 2 of the 5 ancestors have a recall of any class.
  • 6 other devices also cite its predicate K984374.

How does its category compare?

All GAM devices

GAM Suture, Absorbable, Synthetic, Polyglycolic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · GAM

3in 2025

2007: 72008: 62009: 32010: 12011: 22012: 52013: 12014: 102015: 52016: 32017: 82018: 52019: 42020: 32021: 22022: 22023: 12024: 22025: 32026 (partial year): 4
2007high 10 (2014) · low 1 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAM

29in 2025

2007: 50 days median2008: 174 days median2009: 10 days median2012: 31 days median2014: 121 days median2015: 209 days median2016: 169 days median2017: 134 days median2018: 98 days median2019: 90 days median2020: 140 days median2025: 29 days median2026 (partial year): 131 days median
2007high 209 (2015) · low 10 (2009)2026

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

Recalls per year · GAM

1in 2024

2007: 102008: 12009: 62010: 32011: 62016: 12017: 12019: 12020: 442022: 42024: 12026 (partial year): 2
2007high 44 (2020) · low 0 (2012)2026

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

Adverse event reports per year · GAM

8,970in 2025

2007: 2742008: 1942009: 2872010: 5872011: 6372012: 8682013: 8982014: 1,4102015: 9352016: 1,1122017: 1,4992018: 2,2292019: 3,5642020: 3,4152021: 4,5062022: 4,8142023: 5,0702024: 7,2262025: 8,970
2007high 8,970 (2025) · low 194 (2008)2025

MAUDE reports naming product code GAM, 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
200775010274
200861741194
20093106287
20101—3587
20112—6637
20125310868
20131—0898
20141012101,410
201552090935
2016316911,112
2017813411,499
201859802,229
201949013,564
20203140443,415
20212—04,506
20222—44,814
20231—05,070
20242—17,226
202532908,970
202641312—

What is it indicated for?

GLYCOLON® is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

PGA RESORBA® is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not in cardiovascular surgery or neural tissue.

PGA resoquick™ is indicated for use in general soft tissue approximation, including ophthalmic (e.g. conjunctiva) procedures, but not in cardiovascular or neurological procedures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K984374

6 other devices cite the same predicate.

  • K102592SutrazorbVisionary Medical Supplies, Inc. · 2011
  • K080412Absorbable Synthetic Suture with Needle Attachment (Pga Braided)Shanghai Pudong Jinhuan Medical Products Co., Ltd. · 2008
  • K053636Mani Needle & Suture Pack (Pga Absorbable)Mani, Inc. · 20066 recalls
  • K041515Truglyde Absorbable Polyglycolic Acid Surgical SutureSutures India Private Limited · 2005
  • K043539Demetech Sterile Synthetic Absorbable Sutures (Pga) and NeedlesDemetech Corp. · 2005
  • K031443Lsi Solutions Suture Quick Load ProductsLsi Solutions · 2003

More from Resorba Medical GmbH

4 FDA decisions under this applicant name. See the company

  • K181320CaprolonResorba Medical GmbH · 2018
  • K143582Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, SteelResorba Medical GmbH · 2015
  • K141072SupoleneResorba Medical GmbH · 2014

Recent decisions in GAM

The GAM category page

  • K263073Fast Absorbing PGLARiverpoint Medical, LLC · 2026
  • K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureETHICON, Inc. · 2026
  • K253530Trexon™ Monofilament Synthetic Absorbable SutureMedtronic · 2026
  • K253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical SutureETHICON, Inc. · 2026
  • K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue…ETHICON, Inc. · 2025

https://510kreport.com/device/K143584 · printed Nov 6, 2026

Cite this page

510(k) Report. “K143584: Pga Resorba, Pga Resoquick, Glycolon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143584

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026