510(k) Report

510(k) · Cleared

Cleared

Innovasive Devices Y-Knot Suture Clip

K973313510(k) TraditionalCleared Dec 1, 199789-day reviewClass II21 CFR 876.1500

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

Innovasive Devices, Inc. · OCW Endoscopic Tissue Approximation Device

Cleared on Dec 1, 1997 after an 89-day review. The FDA summary names its predicate without a number. 66 later devices descend from it.

Decided
Dec 1, 1997
Review
89 days
Class
Class II
Product code
OCW
Recalls
None
Predicates
0

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

Descendants, by year cleared 2005: 4 descendants cleared1998: 1 descendant cleared2006: 1 descendant cleared2007: 2 descendants cleared2013: 6 descendants cleared2012: 6 descendants cleared2008: 3 descendants cleared2018: 4 descendants cleared2017: 1 descendant cleared2026: 3 descendants cleared2010: 1 descendant cleared2014: 2 descendants cleared2019: 6 descendants cleared2016: 2 descendants cleared2015: 4 descendants cleared2011: 1 descendant cleared2009: 1 descendant cleared2020: 4 descendants cleared2021: 3 descendants cleared2022: 3 descendants cleared2024: 4 descendants cleared2025: 3 descendants cleared2023: 1 descendant cleared1995200020052010201520202025
  1. This deviceK973313 Innovasive Devices Y-Knot Suture ClipInnovasive Devices, Inc. · 1997
  2. Descendant · cites it directly · 64 of its ownK051609 Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005
  3. Descendant · 2 generations on · 31 of its ownK071989 Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical…Surgical Specialties Corp · 2007
  4. Descendant · 2 generations on · 30 of its ownK080680 Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp · 2008
  5. Descendant · 2 generations on · 29 of its ownK080985 Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp · 2008
  6. Descendant · 2 generations on · 26 of its ownK072028 Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp · 2007

Showing 5 of 66 descendants. See all descendants

Descendants cleared per year

1998: 12005: 42006: 12007: 22008: 32009: 12010: 12011: 12012: 62013: 62014: 22015: 42016: 22017: 12018: 42019: 62020: 42021: 32022: 32023: 12024: 42025: 32026: 3
1998high 6 (2012) · low 0 (1999)2026

Most influential descendants

Showing 5 of 66 · See all
  • K051609Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005 · cites it directly64descendants
  • K071989Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture MaterialSurgical Specialties Corp · 2007 · 2 generations on31descendants
  • K080680Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp · 2008 · 2 generations on30descendants
  • K080985Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp · 2008 · 2 generations on29descendants
  • K072028Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp · 2007 · 2 generations on26descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K973313Innovasive Devices Y-Knot Suture ClipInnovasive Devices, Inc.1997—
+1K051609Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc.2005—
+2K071989Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture MaterialSurgical Specialties Corp2007—
+2K080680Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp2008—
+2K080985Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp2008—
+2K072028Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200540
200610
200720
200830
200910
201010
201110
201260
201360
201420
201540
201620
201710
201840
201960
202040
202130
202230
202310
202440
202530
202630
FIG. 1 — Lineage of K973313, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 OCW? 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 OCW device

  1. #1 K252400 Endomina EZFuse systemscore 12.0 · 5 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? (1)

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
*—Ethibond Extra polyester suture
Named without a submission number
—

What descends from it? (66)

See all 66

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

NumberDeviceApplicantDecidedDescendants
K051609Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc.200564
K981631Influence Clip SystemInfluence, Inc.19980

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, K051609 (Quill Medical, Inc., 2005) has gone furthest, with 64 descendants of its own.

How does its category compare?

All OCW devices

OCW Endoscopic Tissue Approximation Device: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OCW

1in 2025

2007: 52008: 42009: 32010: 42011: 12012: 12013: 22016: 22017: 22018: 22019: 12020: 12021: 32023: 32025: 12026 (partial year): 2
2007high 5 (2007) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OCW

133in 2023

2007: 58 days median2008: 70 days median2009: 30 days median2010: 91 days median2021: 221 days median2023: 133 days median
2007high 221 (2021) · low 30 (2009)2026

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

Recalls per year · OCW

3so far in 2026, the most since 2007

2023: 12026 (partial year): 3
2007high 3 (2026) · low 0 (2007)2026

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

Adverse event reports per year · OCW

326in 2025

2007: 92008: 472009: 302010: 102011: 162012: 282013: 22014: 282015: 592016: 742017: 4202018: 4132019: 2912020: 1832021: 1982022: 2352023: 2272024: 2112025: 326
2007high 420 (2017) · low 2 (2013)2025

MAUDE reports naming product code OCW, 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
200755809
2008470047
2009330030
2010491010
20111—016
20121—028
20132—02
20140—028
20150—059
20162—074
20172—0420
20182—0413
20191—0291
20201—0183
202132210198
20220—0235
202331331227
20240—0211
20251—0326
20262—3—

What is it indicated for?

The Intended Use for the Innovasive Y-Knot Suture Clip is for use in general soft tissue approximation and /or ligation with #1 and #2 braided polyester suture.

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

More from Innovasive Devices, Inc.

34 FDA decisions under this applicant name. See the company

  • K994269Titan RC TackInnovasive Devices, Inc. · 2000
  • K993975Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999
  • K992458RC Multisuture Bone Anchor, Model 4453/4454Innovasive Devices, Inc. · 1999
  • K992377RC TackInnovasive Devices, Inc. · 1999
  • K990454Bio-Interference ScrewInnovasive Devices, Inc. · 1999

Recent decisions in OCW

The OCW category page

  • K262044Mediclose Cartridge SystemHealth Value Creation B.V. (trading as Corporis Medical) · 2026
  • K252400Endomina EZFuse systemEndo Tools Therapeutics S.A. · 2026
  • K243750SimpleStitch Suturing SystemEnvision Endoscopy · 2025
  • K231240MaxTack™ Motorized Fixation DeviceCovidien · 2023
  • K213271MedicloseTM SystemHealth Value Creation B.V., Trading AS Corporis Medical · 2023

https://510kreport.com/device/K973313 · printed Nov 4, 2026

Cite this page

510(k) Report. “K973313: Innovasive Devices Y-Knot Suture Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973313

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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