510(k) Report

510(k) · Cleared

Cleared

Gabbay-Frater Suture Guide

K802093510(k) TraditionalCleared Sep 26, 198024-day reviewClass I21 CFR 878.4800

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

Howmedica Corp. · FZX Guide, Surgical, Instrument

Cleared on Sep 26, 1980 after a 24-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.

Decided
Sep 26, 1980
Review
24 days
Class
Class I
Product code
FZX
Recalls
None
Predicates
0

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

Descendants, by year cleared 2016: 2 descendants cleared2020: 2 descendants cleared2024: 1 descendant cleared19801990200020102020
  1. This deviceK802093 Gabbay-Frater Suture GuideHowmedica Corp. · 1980
  2. Descendant · cites it directly · 4 of its ownK153076 silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II…Teleflexmedical, Inc. · 2016
  3. Descendant · 2 generations on · 1 of its ownK192490 Tevdek II, Silky II Polydek, 'Cottony' II, NextStitchTeleflex Medical · 2020
  4. Descendant · 3 generations on · 0 of its ownK241111 AMT Suture PasserApplied Medical Technology, Inc. · 2024
  5. Descendant · 2 generations on · 0 of its ownK193530 Deklene MAXXTeleflex Medical · 2020
  6. Descendant · 2 generations on · 0 of its ownK162396 SILK Surgical SutureTeleflexmedical, Inc. · 2016

Most influential descendants

Showing 5 of 5 · See all
  • K153076silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX…Teleflexmedical, Inc. · 2016 · cites it directly4descendants
  • K192490Tevdek II, Silky II Polydek, 'Cottony' II, NextStitchTeleflex Medical · 2020 · 2 generations on1descendant
  • K241111AMT Suture PasserApplied Medical Technology, Inc. · 2024 · 3 generations on0descendants
  • K193530Deklene MAXXTeleflex Medical · 2020 · 2 generations on0descendants
  • K162396SILK Surgical SutureTeleflexmedical, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K802093Gabbay-Frater Suture GuideHowmedica Corp.1980—
+1K153076silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX…Teleflexmedical, Inc.2016—
+2K192490Tevdek II, Silky II Polydek, 'Cottony' II, NextStitchTeleflex Medical2020—
+3K241111AMT Suture PasserApplied Medical Technology, Inc.2024—
+2K193530Deklene MAXXTeleflex Medical2020—
+2K162396SILK Surgical SutureTeleflexmedical, Inc.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201620
202020
202410
FIG. 1 — Lineage of K802093, 1980–2024Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FZX? 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
Get a 510(k) Report

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? (5)

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

NumberDeviceApplicantDecidedDescendants
K153076silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX…Teleflexmedical, Inc.20164

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, K153076 (Teleflexmedical, Inc., 2016) has gone furthest, with 4 descendants of its own.

How does its category compare?

All FZX devices

FZX Guide, Surgical, Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FZX

FDA has decided no FZX device since 2007.

Median 510(k) review, days · FZX

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

Recalls per year · FZX

1in 2023

2009: 12011: 22013: 42014: 12016: 12017: 12019: 32022: 12023: 1
2007high 4 (2013) · low 0 (2007)2026

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

Adverse event reports per year · FZX

627in 2025

2007: 52008: 62009: 102010: 412011: 272012: 392013: 7252014: 5242015: 4522016: 4662017: 3682018: 4472019: 5352020: 7342021: 7952022: 5812023: 8372024: 8812025: 627
2007high 881 (2024) · low 5 (2007)2025

MAUDE reports naming product code FZX, 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—05
20080—06
20090—110
20100—041
20110—227
20120—039
20130—4725
20140—1524
20150—0452
20160—1466
20170—1368
20180—0447
20190—3535
20200—0734
20210—0795
20220—1581
20230—1837
20240—0881
20250—0627
20260—0—

More from Howmedica Corp.

393 FDA decisions under this applicant name. See the company

  • N17004/S013Surgical Simplex P Bone CementHowmedica Corp. · 2000
  • N17004/S012Surgical Simplex P Radiopaque Bone CementHowmedica Corp. · 2000
  • K983528Micro Dynamic MeshHowmedica Corp. · 1998
  • K983404Type 3 Femoral ComponentsHowmedica Corp. · 19981 recall
  • K980925Duration II Tibial Inserts-Ethylene Oxide SterilizationHowmedica Corp. · 1998

Recent decisions in FZX

The FZX category page

  • K914715Paralleling GuidesImplant Corp. of America · 1994
  • K871413Civco StepperCIVCO Medical Instruments Co., Inc. · 1987
  • K871503Biopsy Needle Guide Kit, SterileAmedic USA · 1987
  • K862564A.C.L. Guide KitAspen Laboratories, Inc. · 1986
  • K854262Meadox Surgimed Breast Localization Wire Set/OnlyMeadox Surgimed, Inc. · 1985

https://510kreport.com/device/K802093 · printed Nov 6, 2026

Cite this page

510(k) Report. “K802093: Gabbay-Frater Suture Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K802093

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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