# K790071: Endoscope and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Corp.
- Decided: Apr 2, 1979 after 81 days
- Product code: GCP (Endoscope, Ac-Powered And Accessories)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
26 later devices descend from it; 5 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K093665: Endo Smartcap (2009), 18 descendants of its own
- K102855: Universal Irrigation Solution Hybrid (2010), 7 descendants of its own
- K103696: Erbeflo Clevercap Hybrid Tubing/Cap Sets for Olympus Models 160 and 180 Series Scopes (2011), 3 descendants of its own
- K132340: Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo Clevercap Hybrid CO2 Tubing/Cap Set for Olympus 160/1 (2013), 2 descendants of its own
- K992141: Olympus Working Element for Probes (1999), 2 descendants of its own

## Recalls of this device
- Nov 11, 2025 · Class II · Z-1454-2026: Complaints of the ceramic tip of the resection sheath breaking have been received.
- Sep 13, 2024 · Class II · Z-0351-2025: Olympus 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, 2024 · Class II · Z-1437-2026: Product 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, 2017 · Class II · Z-0696-2018: Olympus 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 adhes
- Apr 19, 2017 · Class II · Z-2629-2017: Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes.
- Feb 8, 2010 · Not classified · Z-1163-2010: weak weld seams

Source page: https://510kreport.com/device/K790071
Methodology: https://510kreport.com/methodology