# K970712: Laparo-Tenser

- Pathway: 510(k) (Traditional)
- Applicant: L & T S.N.C. DI E. Lucini & C.
- Decided: Jul 21, 1998 after 510 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The Laparo-Tenser is intended for use as a laparoscopic retractor in gasless laparoscopic procedures. the Laparo-Tenser creates a gasless cavity to permit direct viewing of the organs within the peritoneal cavity for the purpose of performing: diagnostic and surgical procedures.

Source page: https://510kreport.com/device/K970712
Methodology: https://510kreport.com/methodology