510(k) Report

510(k) · Cleared

Cleared

Grams Absorbable Surgical Gut Suture Plain & Chromic

K021043510(k) TraditionalCleared Jun 21, 200281-day reviewClass II21 CFR 878.4830

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

Gramsmed, LLC · GAL Suture, Absorbable, Natural

Cleared on Jun 21, 2002 as substantially equivalent to K991223 (Aesculap, Inc., 1999) and 2 other predicates after an 81-day review. Its family tree reaches back 2 generations to 1993.

Decided
Jun 21, 2002
Review
81 days
Class
Class II
Product code
GAL
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K930589 (1993). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 1 other ancestor1999: 1 other ancestorK930589 · Plain, Mild Chromic and Chromic Surgical Gut Sutur · Davis & Geck, Inc. · 1993K994002 · Plain/Chromic Catgut · Trading Consultants and Distributors Intl., Inc. · 200019901992199419961998200020022004
Other ancestors, by generation 1 generation back: 2 other ancestors K994002 · Plain/Chromic Catgut · Trading Consultants and Distributors Intl., Inc. · 2000K930589 · Plain, Mild Chromic and Chromic Surgical Gut Sutur · Davis & Geck, Inc. · 19930
  1. Root · 2 generations backK930589 Plain, Mild Chromic and Chromic Surgical Gut SuturDavis & Geck, Inc. · 1993
  2. 1 generation backK994002 Plain/Chromic CatgutTrading Consultants and Distributors Intl., Inc. · 2000
  3. This deviceK021043 Grams Absorbable Surgical Gut Suture Plain & ChromicGramsmed, LLC · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K930589Plain, Mild Chromic and Chromic Surgical Gut SuturDavis & Geck, Inc.1993—
−1K994002Plain/Chromic CatgutTrading Consultants and Distributors Intl., Inc.2000—
0 (this device)K021043Grams Absorbable Surgical Gut Suture Plain & ChromicGramsmed, LLC2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200010
FIG. 1 — Lineage of K021043, 1993–2002Source: 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 GAL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (3)

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
*K991223Absorbable Surgical Gut Suture, Plain and Chronic and Softcat Absorbable Surgical Gut…
Summary page 1
…stantially equivalent to these predicate devices: o AESCULAP Absorbable Surgical Gut Suture, Plain & Chromic & Softcat Gut Suture, 510K Number K991223, AESCULAP, San Diego California. o T. Cad International, Plain/Chromic Catgut Suture, Trading Consultants& Distributors…
Aesculap, Inc.1999—
*K994002Plain/Chromic Catgut
Summary page 1
…AESCULAP, San Diego California. o T. Cad International, Plain/Chromic Catgut Suture, Trading Consultants& Distributors International Inc. 510K Number K994002, Chicago IL. o CP Medical, Plain and Chromic Absorbable Surgical Gut Suture, 510K Number K001299, CP Medical P…
Trading Consultants and Distributors Intl., Inc.2000—
*K001299Plain and Chromic Gut Absorbable Surgical Sutures Usp
Summary page 1
…istributors International Inc. 510K Number K994002, Chicago IL. o CP Medical, Plain and Chromic Absorbable Surgical Gut Suture, 510K Number K001299, CP Medical Portland Oregon. F. Device Description: Grams Surgical gut suture (Plain and Chromic) is an absorbable s…
Cp Medical20001

Also cleared against K991223: 1 other device →

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 9 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
  • 1 of the 4 ancestors has a recall of any class.
  • 1 other device also cites its predicate K991223.

How does its category compare?

All GAL devices

GAL Suture, Absorbable, Natural: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GAL

1in 2015

2008: 12015: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAL

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

Recalls per year · GAL

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

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

Adverse event reports per year · GAL

117in 2025

2007: 132008: 62009: 252010: 572011: 362012: 272013: 322014: 1572015: 1372016: 872017: 1332018: 2462019: 2292020: 1092021: 1202022: 1302023: 1212024: 1612025: 117
2007high 246 (2018) · low 6 (2008)2025

MAUDE reports naming product code GAL, 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—013
20081—06
20090—025
20100—057
20110—036
20120—027
20130—032
20140—0157
20151—0137
20160—087
20170—0133
20180—0246
20190—1229
20200—0109
20210—0120
20220—0130
20230—0121
20240—0161
20250—0117
20260—0—

What is it indicated for?

Grams Absorbable Surgical Gut Suture (Plain and Chromic) is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures

Indications for use as stated in the FDA summary.

Also cleared against K991223

1 other device cites the same predicate.

  • K072930Demetech Absorbable Surgical Suture Plain & Chromic GutDemetech Corp. · 2008

More from Gramsmed, LLC

7 FDA decisions under this applicant name. See the company

  • K010672Monograms Synthetic Monofilament Absorbable SutureGramsmed, LLC · 2001
  • K003017Gramsorb Synthetic Absorbable SutureGramsmed, LLC · 2001
  • K003590Grams Polyester Nonabsorbable SutureGramsmed, LLC · 2001
  • K002999Grams Polypropylene Nonabsorbable SutureGramsmed, LLC · 2000
  • K003000Grams Nylon Nonabsorbable SutureGramsmed, LLC · 2000

Recent decisions in GAL

The GAL category page

  • K142656Surgical Gut SutureCovidien · 20153 recalls
  • K072930Demetech Absorbable Surgical Suture Plain & Chromic GutDemetech Corp. · 2008
  • K042287Uniplain & UnichromUnited Medical Industries Co., Ltd. · 2005
  • K042897Autobahn Tissue Closure Device and Disposable CartridgeEthicon Endo-Surgery, Inc. · 2004
  • K030227Suturtek Fastclose Suturing DeviceSuturtek Incorporated · 2003

https://510kreport.com/device/K021043 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021043: Grams Absorbable Surgical Gut Suture Plain & Chromic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021043

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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