510(k) Report

510(k) · Cleared

Cleared

Visorb Swift

K023710510(k) TraditionalCleared Jan 17, 200374-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

Cp Medical · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

Cleared on Jan 17, 2003 after a 74-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.

Decided
Jan 17, 2003
Review
74 days
Class
Class II
Product code
GAM
Recalls
None
Predicates
0

6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2014: 2 descendants cleared2013: 1 descendant cleared2024: 1 descendant cleared2018: 1 descendant cleared200020052010201520202025
  1. This deviceK023710 Visorb SwiftCp Medical · 2003
  2. Descendant · cites it directly · 5 of its ownK100461 PDM, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic GutRiverpoint Medical · 2010 · Recalled
  3. Descendant · 2 generations on · 2 of its ownK130737 Synthetic Absorbable SutureFoosin Medical Supplies Inc., Ltd. · 2014
  4. Descendant · 3 generations on · 1 of its ownK142810 WEGO-PGCL Absorbable Surgical Monofilament SutureFoosin Medical Supplies Inc., Ltd. · 2014
  5. Descendant · 2 generations on · 1 of its ownK130083 Demecaprone (Poliglecaprone 25) Synthetic Monofilament (PGCL)…Demetech Corp. · 2013
  6. Descendant · 3 generations on · 0 of its ownK232372 Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)Peters Surgical · 2024

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2010: 12013: 12014: 22018: 12024: 1
2010high 2 (2014) · low 0 (2011)2026

Most influential descendants

Showing 5 of 6 · See all
  • K100461PDM, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic GutRiverpoint Medical · 2010 · cites it directly5descendants
  • K130737Synthetic Absorbable SutureFoosin Medical Supplies Inc., Ltd. · 2014 · 2 generations on2descendants
  • K142810WEGO-PGCL Absorbable Surgical Monofilament SutureFoosin Medical Supplies Inc., Ltd. · 2014 · 3 generations on1descendant
  • K130083Demecaprone (Poliglecaprone 25) Synthetic Monofilament (PGCL) Absorbable SutureDemetech Corp. · 2013 · 2 generations on1descendant
  • K232372Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)Peters Surgical · 2024 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K023710Visorb SwiftCp Medical2003—
+1K100461PDM, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic GutRiverpoint Medical20101
+2K130737Synthetic Absorbable SutureFoosin Medical Supplies Inc., Ltd.2014—
+3K142810WEGO-PGCL Absorbable Surgical Monofilament SutureFoosin Medical Supplies Inc., Ltd.2014—
+2K130083Demecaprone (Poliglecaprone 25) Synthetic Monofilament (PGCL) Absorbable SutureDemetech Corp.2013—
+3K232372Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)Peters Surgical2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201310
201420
201810
202410
FIG. 1 — Lineage of K023710, 2003–2024Source: 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? (2)

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
*—Predicate devices marketed by Ethicon
Named without a submission number
—
*—Predicate devices marketed by B/Braun
Named without a submission number
—

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K100461PDM, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic GutRiverpoint Medical20105

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, K100461 (Riverpoint Medical, 2010) has gone furthest, with 5 descendants of its own.

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.

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?

General soft tissue approximation; including use in Ophthalmic surgery, but not for use in Cardiovascular and Neurological tissue approximation.

Indications for use as stated in the FDA summary.

More from Cp Medical

31 FDA decisions under this applicant name. See the company

  • K094028CP-Fiber (Orthofiber)Cp Medical · 2010
  • K072229MonoswiftCp Medical · 20071 recall
  • K071550Pre-Waxed Needles with Gold Fiduciary MarkersCp Medical · 2007
  • K060987OSCERA7 Synthetic Absorbable Bone Wax, Model OS31Cp Medical · 2006
  • K041894OrthofiberCp Medical · 2004

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/K023710 · printed Nov 4, 2026

Cite this page

510(k) Report. “K023710: Visorb Swift.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023710

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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