# K101937: Hybrid Trocar System

- Pathway: 510(k) (Special)
- Applicant: Aesculap, Inc.
- Decided: Aug 11, 2010 after 30 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K932648 (1993). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942053: Aesculap Interchangeable Trocar Instrument Set, Aesculap, Inc. (1994) Summary page 1.
- K982623: Aesculap Needlescopic Instrument System, Aesculap, Inc. (1998) Summary page 1.
- K071976: Vectec Disposable Trocars and Laparoscopic Accessories, Vectec (2007) Summary page 1.

## Most influential descendants
- K153126: da Vinci Xi Hasson Cone (2015), 0 descendants of its own

## Recalls of this device
- Jan 9, 2024 · Class II · Z-1247-2024: The sterile blister packaging may be damaged, and sterility may be compromised.
- Jan 9, 2024 · Class II · Z-1246-2024: The sterile blister packaging may be damaged, and sterility may be compromised.
- Jan 9, 2024 · Class II · Z-1245-2024: The sterile blister packaging may be damaged, and sterility may be compromised.
- Jan 9, 2024 · Class II · Z-1243-2024: The sterile blister packaging may be damaged, and sterility may be compromised.
- Jan 9, 2024 · Class II · Z-1244-2024: The sterile blister packaging may be damaged, and sterility may be compromised.

## Indications for use
The endoscopic instruments presented in this submission are for use in laparoscopy (abdominal and gynecological surgery) for puncture of the abdominal cavity and establishment of a port of entry for endoscopic instruments.

Source page: https://510kreport.com/device/K101937
Methodology: https://510kreport.com/methodology