510(k) Report

510(k) · Cleared

Cleared

Kittner Dissector

K953059510(k) TraditionalCleared Sep 14, 199576-day reviewClass I21 CFR 878.4450

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

Medical Perspectives Corp. · GDY Gauze/Sponge, Internal, X-Ray Detectable

Cleared on Sep 14, 1995 after a 76-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 265 devices in its family, counting itself, has a Class I recall. 264 later devices descend from it.

Decided
Sep 14, 1995
Review
76 days
Class
Class I
Product code
GDY
Recalls
None
Predicates
0

264 later devices descend from it, 1 citing it directly. 1 of the 265 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1997: 1 descendant cleared2002: 3 descendants cleared2004: 4 descendants cleared2009: 3 descendants cleared2008: 6 descendants cleared2005: 5 descendants cleared2014: 11 descendants cleared2006: 3 descendants cleared2011: 6 descendants cleared2010: 1 descendant cleared2018: 18 descendants cleared2025: 31 descendants cleared2024: 22 descendants cleared2017: 15 descendants cleared2022: 18 descendants cleared2013: 6 descendants cleared2019: 12 descendants cleared2012: 4 descendants cleared2016: 11 descendants cleared2020: 19 descendants cleared2021: 17 descendants cleared2015: 6 descendants cleared2026: 23 descendants cleared2023: 19 descendants cleared, 1 with a Class I recall11995200020052010201520202025
  1. This deviceK953059 Kittner DissectorMedical Perspectives Corp. · 1995
  2. Descendant · cites it directly · 263 of its ownK965001 Intuitive Surgical Monarch Laparoscopic ManipulatorIntuitive Surgical, Inc. · 1997
  3. Descendant · 2 generations on · 260 of its ownK022574 Intuitive Surgical Endoscopic Instrument Control System & Endoscopic…Intuitive Surgical, Inc. · 2002
  4. Descendant · 2 generations on · 260 of its ownK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
  5. Descendant · 2 generations on · 258 of its ownK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
  6. Descendant · 2 generations on · 254 of its ownK013416 Intuitive Surgical Endowrist Endoscopic Instrument FamilyIntuitive Surgical, Inc. · 2002

Showing 5 of 264 descendants. See all descendants

Descendants cleared per year

1997: 12002: 32004: 42005: 52006: 32008: 62009: 32010: 12011: 62012: 42013: 62014: 112015: 62016: 112017: 152018: 182019: 122020: 192021: 172022: 182023: 192024: 222025: 312026: 23
1997high 31 (2025) · low 0 (1998)2026

Class I recalls in this family

  • K223095 Senhance Surgical System5 generations on · 2023

Most influential descendants

Showing 5 of 264 · See all
  • K965001Intuitive Surgical Monarch Laparoscopic ManipulatorIntuitive Surgical, Inc. · 1997 · cites it directly263descendants
  • K022574Intuitive Surgical Endoscopic Instrument Control System & Endoscopic Instruments, Model…Intuitive Surgical, Inc. · 2002 · 2 generations on260descendants
  • K021036Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · 2 generations on260descendants
  • K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic…Intuitive Surgical, Inc. · 2004 · 2 generations on258descendants
  • K013416Intuitive Surgical Endowrist Endoscopic Instrument FamilyIntuitive Surgical, Inc. · 2002 · 2 generations on254descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K953059Kittner DissectorMedical Perspectives Corp.1995—
+1K965001Intuitive Surgical Monarch Laparoscopic ManipulatorIntuitive Surgical, Inc.1997—
+2K022574Intuitive Surgical Endoscopic Instrument Control System & Endoscopic…Intuitive Surgical, Inc.2002—
+2K021036Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc.200218
+2K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc.2004—
+2K013416Intuitive Surgical Endowrist Endoscopic Instrument FamilyIntuitive Surgical, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200230
200440
200550
200630
200860
200930
201010
201160
201240
201360
2014110
201560
2016110
2017150
2018180
2019120
2020190
2021170
2022180
2023191
2024220
2025310
2026230
FIG. 1 — Lineage of K953059, 1995–2026Source: 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.

1 device in this family has a Class I recall. 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? (264)

See all 264

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

NumberDeviceApplicantDecidedDescendants
K965001Intuitive Surgical Monarch Laparoscopic ManipulatorIntuitive Surgical, Inc.1997263

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K223095Senhance Surgical SystemAsensus Surgical, Inc. · 2023 · 5 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K965001 (Intuitive Surgical, Inc., 1997) has gone furthest, with 263 descendants of its own.

How does its category compare?

All GDY devices

GDY Gauze/Sponge, Internal, X-Ray Detectable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GDY

FDA has decided no GDY device since 2007.

Median 510(k) review, days · GDY

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

Recalls per year · GDY

1in 2022

2008: 12010: 72012: 22015: 22017: 12018: 12019: 12022: 12026 (partial year): 1, 1 Class I
2007high 7 (2010) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GDY

112in 2025

2007: 152008: 252009: 962010: 442011: 382012: 802013: 402014: 652015: 1222016: 2912017: 2522018: 2502019: 1772020: 1162021: 1342022: 2262023: 982024: 1142025: 112
2007high 291 (2016) · low 15 (2007)2025

MAUDE reports naming product code GDY, 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—015
20080—125
20090—096
20100—744
20110—038
20120—280
20130—040
20140—065
20150—2122
20160—0291
20170—1252
20180—1250
20190—1177
20200—0116
20210—0134
20220—1226
20230—098
20240—0114
20250—0112
20260—1 (1)—

More from Medical Perspectives Corp.

7 FDA decisions under this applicant name. See the company

  • K953087Cherry Pit DissectorMedical Perspectives Corp. · 1995
  • K953058Round Stick Sponges, Flat Stick SpongesMedical Perspectives Corp. · 1995
  • K953088Triangular SpongesMedical Perspectives Corp. · 1995
  • K953057Cylindrical SpongeMedical Perspectives Corp. · 1995
  • K953060Rosebud DissectorMedical Perspectives Corp. · 1995

Recent decisions in GDY

The GDY category page

  • K972634Ultracell Suction SpongeUltracell Medical Technologies, Inc. · 1997
  • K960236CPR Lap SpongesCustom Pack Reliability · 1996
  • K955599Stryker Femoral Canal Sponge & Acetabulum SpongeStryker Corp. · 19965 recalls
  • K955322Protec X-Ray Detectable Gauze SpongeDerivados DE Gasa, S.A. DE C.V. · 1995
  • K953830KensorbKentron Health Care, Inc. · 1995

https://510kreport.com/device/K953059 · printed Nov 4, 2026

Cite this page

510(k) Report. “K953059: Kittner Dissector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K953059

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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