# K955403: Oes Laparo-Thoraco Videoscope Type V

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Mar 11, 1996 after 105 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K923982 (1993). 4 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942838: Olympus Superview Laparoscope for OB/Gyn, Olympus America, Inc. (1995). Our OCR of the scanned summary read K942338, FDA’s number for Olympus PF-8P Oes Pancreato Fiberscope and Accessories (Olympus Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Olympus Flexible TipThoracoscope/ Laparoscope”.
- K942839: Olympus Superview Laparoscope for General Surgery, Olympus America, Inc. (1994). Our OCR of the scanned summary read K942339, FDA’s number for Skin Neuveau Scar Treatment (Puritas Health Care, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Olympus Flexible TipThoracoscope/ Laparoscope”.
- K915857: Flexible Tip Thoracoscope/Laparoscope, Olympus Corp. (1994) Summary page 2.
- K923982: Olympus Oes Laparoscopy System, Olympus Corp. (1993) Summary page 2.
- (no number) Lens Cleaner (Cook): named in the summary without a submission number
- (no number) Optic Shaft (Wiest): named in the summary without a submission number
- (no number) Lap Wash System (DevMed Group Inc.): named in the summary without a submission number

## Most influential descendants
- K053382: Laparo-Thoraco Videoscope XLTF-Vaw (2006), 8 descendants of its own
- K081173: Endoscopic CO2 Regulation Unit Ucr (2008), 4 descendants of its own
- K111648: Bracco Diagnostics, Inc. CO2MPACT Endodcopic Insufflator (2011), 3 descendants of its own
- K100533: Vista Endoscope,89 CM, 56CM , Scout Blunt-Tipped Guide- 106 CM, 86 CM, 53 CM, Models FG0027, FG0031, FG0029, FG 0028, (2011), 1 descendant of its own
- K201096: CO2mbiLED (2020), 0 descendants of its own

## Indications for use
OES Laparo-Thoraco Videoscope Type V The OES Laparo- Thoraco Videoscope Type V has been designed for endoscopic observation, diagnosis and treatment within the thoracic and abdominal cavity. A4907 Lens Cleaning Sheath The A4907 Lens Cleaning Sheath has been specifically designed to be used with an OES Laparo-Thoraco Videoscope Type V to clean the objective lens surface. A4908 Valve The A4908 Valve has been specifically designed for use in conjunction with the A4907 Cleaning Sheath to provide irrigation and aspiration of liquids when connected to the insertion tube of the Olympus videoscope. Trocar Tube and Trocars The trocar tubes are intended to provide a passageway for the endoscope or hand instruments, and permit the insufflation of CO, during the endoscopic procedure. The subject trocar tubes are specifically designed to use in conjunction with the OES Laparo-Thoraco Videoscope Type V. The trocars are intended to pierce the abdominal wall tissue layer during the endoscopic procedure. The subject trocars are specifically designed to use in conjunction with the Laparo-Thoracoscope.

Source page: https://510kreport.com/device/K955403
Methodology: https://510kreport.com/methodology