510(k) · Cleared
ClearedEndoscopes W/Permanent and Removable Eyepiece, Panoview Plus Telescope W/Plug-on Connector
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 6, 1997 as substantially equivalent to K951519 (Wells Johnson Co., 1995) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Nov 6, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K930667 (1994). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 1 generation backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
- This deviceK972927 Endoscopes W/Permanent and Removable Eyepiece, Panoview Plus…Richard Wolf Medical Instruments Corp. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| −1 | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line… | Snowden-Pencer | 1996 | — |
| 0 (this device) | K972927 | Endoscopes W/Permanent and Removable Eyepiece, Panoview Plus Telescope… | Richard Wolf Medical Instruments Corp. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 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? (4)
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 |
|---|---|---|---|
| * | K951519 | Weco Endoscopic System with Fiber Optic LightSummary page 1…scope, Plastic and General Surgery Information on devices to which substantial equivalence is claimed: 510(k) Number Trade or proprietary or model name Manufacturer 1 K951519 1 WECO Endoscopic System w/ Fiber Optic 1 Wells Endoscopic Light Company 2 2 Endoscope 2 Storz 3 3 EndoPlastic™ Scope, 10mm 3 S… | 1995 |
| * | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line Instruments/Diamond-Port…Summary page 1…Manufacturer 1 K951519 1 WECO Endoscopic System w/ Fiber Optic 1 Wells Endoscopic Light Company 2 2 Endoscope 2 Storz 3 3 EndoPlastic™ Scope, 10mm 3 Snowden-Pencer 4 K960400 4 Diamond-View™ Non-Autoclavable 4 Snowden-Pencer Endoscopes, 10mm 5 5 5 1.0 Description The Richard Wolf Endoscopes have 4mm,… | 1996 |
| * | — | Endoscope (Storz) Named without a submission number | |
| * | — | EndoPlastic™ Scope, 10mm (Snowden-Pencer) Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
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?
Richard Wolf endoscopes for use in plastic surgery. are designed to visualize anatomy through natural and man-made openings in body cavities. The endoscope(s) may be used to visualize subcutaneous tissue when the indicated application is endoscopic plastic/reconstructive surgery.
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/K972927 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972927: Endoscopes W/Permanent and Removable Eyepiece, Panoview Plus Telescope W/Plug-on Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972927
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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