# K070913: Self-Light Disposable Anoscope

- Pathway: 510(k) (Traditional)
- Applicant: Sapimed S.P.A.
- Decided: Aug 10, 2007 after 130 days
- Product code: FER (Anoscope And Accessories)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K993738 (2000). 4 ancestors in all.
11 later devices descend from it; 5 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020702: O'regan Disposable Anoscope, Canadian Theatre Products, Ltd. (2002) Summary page 1.
- K810227: Model #53110 Disposable Anoscope, Welch Allyn, Inc. (1981) Summary page 1.
- K954614: Eos Brand Disposable Proctoscope, North Eos Industries, Inc. (1996) Summary page 1.

## Most influential descendants
- K080132: THD Disposable Anoscope/Proctoscope (2008), 6 descendants of its own
- K091490: Family of THD Disposable Anoscopes/Proctoscopes/Rectoscopes (2009), 4 descendants of its own
- K103647: THD Disposable Anoscopes, Proctoscopes and Rectoscopes (2011), 3 descendants of its own
- K121135: THD Anoscope, Proctoscope, Rectoscope, Rectoscope and Light-Scope (2012), 1 descendant of its own
- K250645: SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) (2025), 0 descendants of its own

## Recalls of this device
- Apr 23, 2021 · Class II · Z-1901-2021: Due to issue with product sterility. Sterilization service provider had falsified records.

## Indications for use
The Sapimed Self Light® Disposable Anoscopes are intended for physician use to examine the anal sphincter and anus, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K070913
Methodology: https://510kreport.com/methodology