510(k) Report

510(k) · Cleared

Cleared

Auto Suture PSS Skin Stapling Instrument

K810187510(k) TraditionalCleared Mar 20, 198157-day reviewClass I21 CFR 874.4420

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

United States Surgical, A Division of Tyco Healthc · KBC Saw, Nasal

Cleared on Mar 20, 1981 after a 57-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Mar 20, 1981
Review
57 days
Class
Class I
Product code
KBC
Recalls
None
Predicates
0

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

Descendants, by year cleared 1996: 1 descendant cleared1998: 1 descendant cleared2002: 1 descendant cleared19801990200020102020
  1. This deviceK810187 Auto Suture PSS Skin Stapling InstrumentUnited States Surgical, A Division of Tyco Healthc · 1981
  2. Descendant · cites it directly · 2 of its ownK955748 Doyle ExtractorSafetech Intl., Inc. · 1996
  3. Descendant · 2 generations on · 1 of its ownK973497 HuberlocMedcare Medical Group, Inc. · 1998
  4. Descendant · 3 generations on · 0 of its ownK021916 Harmac Huber Needle Safety Device, H2984001Harmac Medical Products, Inc. · 2002

Most influential descendants

Showing 3 of 3 · See all
  • K955748Doyle ExtractorSafetech Intl., Inc. · 1996 · cites it directly2descendants
  • K973497HuberlocMedcare Medical Group, Inc. · 1998 · 2 generations on1descendant
  • K021916Harmac Huber Needle Safety Device, H2984001Harmac Medical Products, Inc. · 2002 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K810187Auto Suture PSS Skin Stapling InstrumentUnited States Surgical, A Division of Tyco Healthc1981—
+1K955748Doyle ExtractorSafetech Intl., Inc.1996—
+2K973497HuberlocMedcare Medical Group, Inc.1998—
+3K021916Harmac Huber Needle Safety Device, H2984001Harmac Medical Products, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199810
200210
FIG. 1 — Lineage of K810187, 1981–2002Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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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? (3)

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

NumberDeviceApplicantDecidedDescendants
K955748Doyle ExtractorSafetech Intl., Inc.19962

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, K955748 (Safetech Intl., Inc., 1996) has gone furthest, with 2 descendants of its own.

How does its category compare?

All KBC devices

KBC Saw, Nasal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KBC

FDA has decided no KBC device since 2007.

Median 510(k) review, days · KBC

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

Recalls per year · KBC

No recall names KBC since 2007.

Adverse event reports per year · KBC

No MAUDE report names KBC since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from United States Surgical, A Division of…

218 FDA decisions under this applicant name. See the company

  • K071406Autosuture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 2007
  • K071920Autosuture Absorbable Tack and ApplicatorUnited States Surgical, A Division of Tyco Healthc · 2007
  • K061288Auto Suture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 2006
  • K062850Autosuture Circular Eea Surgical StaplersUnited States Surgical, A Division of Tyco Healthc · 2006
  • K062326Autosuture Modified Versaport Trocar with Fixation SleeveUnited States Surgical, A Division of Tyco Healthc · 2006

Recent decisions in KBC

The KBC category page

  • K811887Skin Staple ExtractorSierra Laboratories, Inc. · 1981
  • K810188Auto Suture Gas Powered Disp. LDS StaplUnited States Surgical, A Division of Tyco Healthc · 1981
  • K772379Joseph SawEdward Weck, Inc. · 1978

https://510kreport.com/device/K810187 · printed Nov 5, 2026

Cite this page

510(k) Report. “K810187: Auto Suture PSS Skin Stapling Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K810187

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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