510(k) Report

510(k) · Cleared

Recalled · Class II · 2025

Endoscope and Accessories

K790071510(k) TraditionalCleared Apr 2, 197981-day reviewClass II21 CFR 876.1500Recalls 6

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

Olympus Corp. · GCP Endoscope, Ac-Powered And Accessories

Cleared on Apr 2, 1979 after an 81-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 26 later devices descend from it. It has been recalled 6 times.

Decided
Apr 2, 1979
Review
81 days
Class
Class II
Product code
GCP
Recalls
6
Predicates
0

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

Descendants, by year cleared 1999: 2 descendants cleared1998: 1 descendant cleared1996: 1 descendant cleared2009: 1 descendant cleared2020: 2 descendants cleared2019: 2 descendants cleared2010: 1 descendant cleared2023: 4 descendants cleared2024: 1 descendant cleared2021: 1 descendant cleared2014: 1 descendant cleared2011: 1 descendant cleared2017: 1 descendant cleared2005: 1 descendant cleared2006: 1 descendant cleared2022: 3 descendants cleared2013: 1 descendant cleared2016: 1 descendant cleared19801990200020102020
  1. This deviceK790071 Endoscope and AccessoriesOlympus Corp. · 1979
  2. Descendant · cites it directly · 18 of its ownK093665 Endo SmartcapByrne Medical, Inc. · 2009 · Recalled
  3. Descendant · 2 generations on · 7 of its ownK102855 Universal Irrigation Solution HybridByrne Medical, Inc. · 2010
  4. Descendant · 2 generations on · 3 of its ownK103696 Erbeflo Clevercap Hybrid Tubing/Cap Sets for Olympus Models 160 and…Erbe USA, Inc. · 2011
  5. Descendant · 3 generations on · 2 of its ownK132340 Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo…Erbe USA, Inc. · 2013 · Recalled
  6. Descendant · cites it directly · 2 of its ownK992141 Olympus Working Element for ProbesOlympus Winter & Ibe GmbH · 1999

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

1996: 11998: 11999: 22005: 12006: 12009: 12010: 12011: 12013: 12014: 12016: 12017: 12019: 22020: 22021: 12022: 32023: 42024: 1
1996high 4 (2023) · low 0 (1997)2026

Most influential descendants

Showing 5 of 26 · See all
  • K093665Endo SmartcapByrne Medical, Inc. · 2009 · cites it directly18descendants
  • K102855Universal Irrigation Solution HybridByrne Medical, Inc. · 2010 · 2 generations on7descendants
  • K103696Erbeflo Clevercap Hybrid Tubing/Cap Sets for Olympus Models 160 and 180 Series ScopesErbe USA, Inc. · 2011 · 2 generations on3descendants
  • K132340Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo Clevercap Hybrid CO2…Erbe USA, Inc. · 2013 · 3 generations on2descendants
  • K992141Olympus Working Element for ProbesOlympus Winter & Ibe GmbH · 1999 · cites it directly2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K790071Endoscope and AccessoriesOlympus Corp.1979—
+1K093665Endo SmartcapByrne Medical, Inc.20097
+2K102855Universal Irrigation Solution HybridByrne Medical, Inc.2010—
+2K103696Erbeflo Clevercap Hybrid Tubing/Cap Sets for Olympus Models 160 and 180 Series…Erbe USA, Inc.2011—
+3K132340Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo Clevercap…Erbe USA, Inc.20131
+1K992141Olympus Working Element for ProbesOlympus Winter & Ibe GmbH1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199810
199920
200510
200610
200910
201010
201110
201310
201410
201610
201710
201920
202020
202110
202230
202340
202410
FIG. 1 — Lineage of K790071, 1979–2024Source: 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 GCP? 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? (26)

See all 26

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K093665Endo SmartcapByrne Medical, Inc.200918
K992141Olympus Working Element for ProbesOlympus Winter & Ibe GmbH19992
K983811Unipolar Optical Biopsy ForcepsOlympus Winter & Ibe GmbH19981
K990237Trocar System According to HassonOlympus America, Inc.19990
K950719Oes UrologyOlympus America, Inc.19960

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 11, 2025Class IIZ-1454-2026Under Investigation by firmComplaints of the ceramic tip of the resection sheath breaking have been received.
Sep 13, 2024Class IIZ-0351-2025Under Investigation by firmOlympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from the Instruction for Use (IFU) due to the potential for a damaged tip during use of a laser probe.
Sep 13, 2024Class IIZ-1437-2026Under Investigation by firmProduct being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device.
Aug 18, 2017Class IIZ-0696-2018Component change controlOlympus has received complaints about fragments of adhesive which detached from inside the working channel of the referenced products. Cracking, chipping, missing pieces, and delamination of the adhesive have also been reported. In one…
Apr 19, 2017Class IIZ-2629-2017Under Investigation by firmLoop wires breaking at the distal end of the Monopolar HF Resection Electrodes.
Feb 8, 2010Not classifiedZ-1163-2010Nonconforming Material/Componentweak weld seams

The 5 latest of 6 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K093665 (Byrne Medical, Inc., 2009) has gone furthest, with 18 descendants of its own.

How does its category compare?

All GCP devices

GCP Endoscope, Ac-Powered And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCP

FDA has decided no GCP device since 2007.

Median 510(k) review, days · GCP

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

Recalls per year · GCP

1in 2024

2017: 12024: 1
2007high 1 (2017) · low 0 (2007)2026

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

Adverse event reports per year · GCP

180in 2025

2015: 42016: 132017: 1172018: 262019: 192020: 182021: 122022: 262023: 1002024: 1082025: 180
2007high 180 (2025) · low 0 (2007)2025

MAUDE reports naming product code GCP, 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—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—04
20160—013
20170—1117
20180—026
20190—019
20200—018
20210—012
20220—026
20230—0100
20240—1108
20250—0180
20260—0—

More from Olympus Corp.

142 FDA decisions under this applicant name. See the company

  • K915402EW-10 and EW-20Olympus Corp. · 1995
  • K933200Olympus PBD StentsOlympus Corp. · 19954 recalls
  • K942338Olympus PF-8P Oes Pancreato Fiberscope and AccessoriesOlympus Corp. · 1994
  • K931763HF-Resection Electrode, Loop W/Runner Endos/AccessOlympus Corp. · 1994
  • K934835FlovalOlympus Corp. · 1994

Recent decisions in GCP

The GCP category page

  • K954614Eos Brand Disposable ProctoscopeNorth Eos Industries, Inc. · 1996
  • K896505Porges Universal HandlesPorges Corp. · 1990
  • K896008Model 6500 Mercury Arc Light SourceMedical Dynamics, Inc. · 1989
  • K862424Steerable Catheter SystemEndovations · 1986
  • K860103Mod. Endoport Single-Use Trocar and SleeveEndotherapeutics · 1986

https://510kreport.com/device/K790071 · printed Nov 6, 2026

Cite this page

510(k) Report. “K790071: Endoscope and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K790071

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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