# K982623: Aesculap Needlescopic Instrument System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Sep 30, 1998 after 64 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: 2 generations back to K912544 (1991). 10 ancestors in all.
17 later devices descend from it; 3 cite it directly.
0 of 28 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 2.
- K941239: Aesculap Neuroendoscope, Aesculap, Inc. (1994) Summary page 2.
- K942730: Aesculap Laparoscopes, Aesculap, Inc. (1995) Summary page 2.
- K940936: Aesculap Endoscopic Instruments, Aesculap, Inc. (1994) Summary page 2.
- K965055: Imagyn Microlap and Micro Lap-Gold Laparoscopes, Imagyn Medical, Inc. (1997) Summary page 2.
- K962799: Miniature Laparoscope Set (Mini Lap), Richard Wolf GmbH (1996) Summary page 2.
- K955479: Koh Micro-Suturing Instruments, KARL STORZ Endoscopy-America, Inc. (1995) Summary page 2.
- K946164: KS Semi-Rigid Micro-Endoscopes and Accessories for Adult and Pediatric General Endospocic and Laparoscopic Surgical Pros, KARL STORZ Endoscopy-America, Inc. (1995) Summary page 2.
- K972415: Minisite*Bipolar Forceps** Device, United States Surgical, A Division of Tyco Healthc (1997) Summary page 2.
- (no number) Micro-L Laparoscopy System: named in the summary without a submission number

## Most influential descendants
- K123102: Sovereign Mini (2013), 13 descendants of its own
- K173919: HX Device (2018), 8 descendants of its own
- K203603: Monopolar Hook (2021), 3 descendants of its own
- K143299: Percuvance (R) Percutaneous Surgical System (2015), 2 descendants of its own
- K153063: Percuvance  Percutaneous Surgical System (2016), 1 descendant of its own

## Indications for use
Aesculap's Needlescopic Instrument System (N.I.S.) is indicated for use in adult and pediatric diagnostic and therapeutic general endoscopy and laparoscopy surgery.

Source page: https://510kreport.com/device/K982623
Methodology: https://510kreport.com/methodology