# K160393: AdTec

- Pathway: 510(k) (Special)
- Applicant: Aesculap, Inc.
- Decided: May 26, 2016 after 105 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K945975 (1994). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123102: Sovereign Mini, Aesculap, Inc. (2013) Summary page 4.
- K940936: Aesculap Endoscopic Instruments, Aesculap, Inc. (1994) Summary page 4.
- K001330: Sovereign Bipolar Instruments, Aesculap, Inc. (2000) Summary page 4.

## Indications for use
Aesculap's AdTec® is indicated for use in adult and pediatric (3.5mm instruments only) diagnostic and therapeutic general endoscopy and laparoscopy surgery.

Source page: https://510kreport.com/device/K160393
Methodology: https://510kreport.com/methodology