510(k) · Cleared
ClearedInstruments for Endoscopic Plastic Surgery (Eps)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Nov 5, 1998 after a 295-day review. The FDA summary names its predicate without a number. 11 later devices descend from it.
- Decided
- Nov 5, 1998
- Review
- 295 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 1 citing it directly.
- This deviceK980129 Instruments for Endoscopic Plastic Surgery (Eps)Richard Wolf Medical Instruments Corp. · 1998
- Descendant · cites it directly · 10 of its ownK993655 Micro-France Electrosurgical Instruments, VariousXomed, Inc. · 1999 · Recalled
- Descendant · 2 generations on · 3 of its ownK150959 Sutter Bipolar Forceps-CalvianSutter Medizintechnik GmbH · 2015
- Descendant · 3 generations on · 2 of its ownK172368 Bipolar Micro-Coagulation ForcepsGunter Bissinger Medizintechnik GmbH · 2018
- Descendant · 2 generations on · 2 of its ownK024304 Microsurgical Bipolar HandpieceNeomedix Corp. · 2003
- Descendant · 2 generations on · 1 of its ownK080257 Microfrance Laparoscopic Manual Surgical InstrumentsMedtronic Xomed, Inc. · 2008
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K993655Micro-France Electrosurgical Instruments, VariousXomed, Inc. · 1999 · cites it directly10descendants
- K150959Sutter Bipolar Forceps-CalvianSutter Medizintechnik GmbH · 2015 · 2 generations on3descendants
- K172368Bipolar Micro-Coagulation ForcepsGunter Bissinger Medizintechnik GmbH · 2018 · 3 generations on2descendants
- K024304Microsurgical Bipolar HandpieceNeomedix Corp. · 2003 · 2 generations on2descendants
- K080257Microfrance Laparoscopic Manual Surgical InstrumentsMedtronic Xomed, Inc. · 2008 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980129 | Instruments for Endoscopic Plastic Surgery (Eps) | Richard Wolf Medical Instruments Corp. | 1998 | — |
| +1 | K993655 | Micro-France Electrosurgical Instruments, Various | Xomed, Inc. | 1999 | 2 |
| +2 | K150959 | Sutter Bipolar Forceps-Calvian | Sutter Medizintechnik GmbH | 2015 | — |
| +3 | K172368 | Bipolar Micro-Coagulation Forceps | Gunter Bissinger Medizintechnik GmbH | 2018 | — |
| +2 | K024304 | Microsurgical Bipolar Handpiece | Neomedix Corp. | 2003 | — |
| +2 | K080257 | Microfrance Laparoscopic Manual Surgical Instruments | Medtronic Xomed, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GCJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Existing pre-enactment devices sold by Richard Wolf Named without a submission number | |
| * | — | 510(k) devices sold by Karl Storz Named without a submission number |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993655 | Micro-France Electrosurgical Instruments, Various | 1999 | 10 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K993655 (Xomed, Inc., 1999) has gone furthest, with 10 descendants of its own.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
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…
Read the full statement (327 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980129 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980129: Instruments for Endoscopic Plastic Surgery (Eps).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980129
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026