510(k) Report

510(k) · Cleared

Cleared

Surgistar Blades

K923689510(k) TraditionalCleared Sep 9, 199247-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

Surgistar, Inc. · GDX Scalpel, One-Piece

Cleared on Sep 9, 1992 after a 47-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Sep 9, 1992
Review
47 days
Class
Class I
Product code
GDX
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K923689Source: 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.

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, 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 GDX devices

GDX Scalpel, One-Piece: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GDX

FDA has decided no GDX device since 2007.

Median 510(k) review, days · GDX

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

Recalls per year · GDX

1in 2013

2010: 32013: 1
2007high 3 (2010) · low 0 (2007)2026

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

Adverse event reports per year · GDX

3in 2025

2007: 42008: 12009: 52010: 32011: 22012: 42013: 22014: 82015: 22016: 22017: 42018: 12019: 62020: 82021: 212022: 52023: 52024: 32025: 3
2007high 21 (2021) · low 1 (2008)2025

MAUDE reports naming product code GDX, 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—04
20080—01
20090—05
20100—33
20110—02
20120—04
20130—12
20140—08
20150—02
20160—02
20170—04
20180—01
20190—06
20200—08
20210—021
20220—05
20230—05
20240—03
20250—03
20260—0—

More from Surgistar, Inc.

4 FDA decisions under this applicant name. See the company

  • K030891Surgistar Microkeratome Blade, Model NO. 2400-LSKSurgistar, Inc. · 2003
  • K992978Ricrokeratome BladeSurgistar, Inc. · 1999
  • K941747Surgistar TrocarsSurgistar, Inc. · 1994

Recent decisions in GDX

The GDX category page

  • K921167UltrabladeMicron Technology, Inc. · 1992
  • K914086Ican Cylindrical SpongesIcn Pharmaceuticals, Inc. · 1991
  • K904505Cci Corneal ScarifierBuckman Co., Inc. · 1991
  • K9053801-Cut Acl Graft KnifeDepuy, Inc. · 1990
  • K895682Vessel LoopsApplied Medical Technologies · 1989

https://510kreport.com/device/K923689 · printed Nov 4, 2026

Cite this page

510(k) Report. “K923689: Surgistar Blades.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K923689

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