# K980129: Instruments for Endoscopic Plastic Surgery (Eps)

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Nov 5, 1998 after 295 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
No predicates in its family tree.
11 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Existing pre-enactment devices sold by Richard Wolf: named in the summary without a submission number
- (no number) 510(k) devices sold by Karl Storz: named in the summary without a submission number

## Most influential descendants
- K993655: Micro-France Electrosurgical Instruments, Various (1999), 10 descendants of its own
- K150959: Sutter Bipolar Forceps-Calvian (2015), 3 descendants of its own
- K172368: Bipolar Micro-Coagulation Forceps (2018), 2 descendants of its own
- K024304: Microsurgical Bipolar Handpiece (2003), 2 descendants of its own
- K080257: Microfrance Laparoscopic Manual Surgical Instruments (2008), 1 descendant of its own

## Indications for use
Endoscopes are designed to visualize anatomy through natural and man-made openings in body cavities. Retraction Sheaths are used to form an artificial working access. The introduction of a telescope permits illumination and observation of the operating site. The rotatable stopcock permits continuous irrigation. The retraction sheaths are used in endoscopic plastic surgery in endo-facelift, eyebrow and forehead lift specialties. The Obturator (mandrin) is used in conjunction with the sheath for atraumatic insertion into body cavities. The Optical Retractors are used to maintain a subcutaneous space during surgical procedures for plastic/cosmetic and reconstructive surgery. They can be combined with an endoscope to visualize the tissue and anatomic structures. The Optical Holders with optical retractors allow single-handled maintenance of subcutaneous pocket while providing traction. One hand is free for dissection. The optical holder or a guide holds the endoscope in position under the blade of the retractor. Suction/Irrigation Instruments are used to keep the operating site and the endoscope free of blood and secretion; at the same time it serves as a retractor to hold tissue out of the way. The instrument is used in endoscopic surgery of the nose, nasal sinuses, and in endoscopic plastic surgery. The Micro Grasping Forceps with HF are used to grasp and to coagulate small blood vessels. The HF Coagulation Suction Aspirator suctions and coagulates while holding tissue out of the way during the endoscopic operation, e.g. of the larynx in connection with CO, lasers, in mediastinoscopy or in plastic surgery. The Bipolar Coagulation suction Tube (bipolar aspiration tube) is used for aspiration and coagulation of small lesions. The Bipolar Coagulation Instrument is designed for used in plastic/cosmetic and reconstructive surgery to coagulate small blood vessels that bleed from blunt dissection of subcutaneous tissue. Smoke caused by cauterization of tissue is evacuated from the operative site when used in conjunction with the suction applicator. Bipolar electrodes are used to coagulate and to remove or destroy tissue by the use of bipolar HF current.

Source page: https://510kreport.com/device/K980129
Methodology: https://510kreport.com/methodology