510(k) Report

510(k) · Cleared

Cleared

Gorsk Sponge Containment System

K873555510(k) TraditionalCleared Oct 23, 198756-day reviewClass I21 CFR 880.2740

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

Gorsk, Inc. · LWH Counter, Sponge, Surgical

Cleared on Oct 23, 1987 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 23, 1987
Review
56 days
Class
Class I
Product code
LWH
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K873555Source: FDA 510(k) database · 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 LWH? 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

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.

How does its category compare?

All LWH devices

LWH Counter, Sponge, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LWH

2in 2012

2007: 22009: 12010: 12012: 2
2007high 2 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LWH

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

Recalls per year · LWH

1in 2013

2013: 12026 (partial year): 1
2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · LWH

34in 2025

2007: 12008: 12009: 22010: 32011: 142012: 62013: 52014: 162015: 82016: 402017: 1072018: 642019: 662020: 332021: 352022: 412023: 392024: 372025: 34
2007high 107 (2017) · low 1 (2007)2025

MAUDE reports naming product code LWH, 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
20072—01
20080—01
20091—02
20101—03
20110—014
20122—06
20130—15
20140—016
20150—08
20160—040
20170—0107
20180—064
20190—066
20200—033
20210—035
20220—041
20230—039
20240—037
20250—034
20260—1—

More from Gorsk, Inc.

2 FDA decisions under this applicant name. See the company

  • K873554Gorsk Instrument RestGorsk, Inc. · 1987

Recent decisions in LWH

The LWH category page

  • K121274Pixel AppGauss Surgical, Inc., · 2012
  • K120473Pixel AppGauss Surgical, Inc., · 2012
  • K100551Orlocate System Model Orl 100Haldor Advanced Technologies, Ltd. · 2010
  • K093557Smartwand-DTXClearcount Medical Solutions · 2009
  • K073180Smartsponge Plus SystemClearcount Medical Solutions, Inc. · 2007

https://510kreport.com/device/K873555 · printed Nov 6, 2026

Cite this page

510(k) Report. “K873555: Gorsk Sponge Containment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K873555

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026