510(k) · Cleared
ClearedStandard Clamp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Standard Bariatrics · GCJ Laparoscope, General & Plastic Surgery
Cleared on Oct 24, 2016 as substantially equivalent to K153358 (Standard Bariatrics, 2016) and 1 other predicate after a 124-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it.
- Decided
- Oct 24, 2016
- Review
- 124 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K944467 (1994). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK944467 Aesculap Manual Laparoscopic InstrumentsAesculap, Inc. · 1994
- This deviceK161720 Standard ClampStandard Bariatrics · 2016
- Descendant · cites it directly · 1 of its ownK170379 Disposable Standard ClampStandard Bariatrics · 2017
- Descendant · 2 generations on · 0 of its ownK181608 Disposable Standard ClampStandard Bariatrics · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944467 | Aesculap Manual Laparoscopic Instruments | Aesculap, Inc. | 1994 | — |
| 0 (this device) | K161720 | Standard Clamp | Standard Bariatrics | 2016 | — |
| +1 | K170379 | Disposable Standard Clamp | Standard Bariatrics | 2017 | — |
| +2 | K181608 | Disposable Standard Clamp | Standard Bariatrics | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K153358 | Standard ClampSummary page 4…lassification Name: Endoscope and accessories (GCJ, 21 CFR 876.1500) Legally Marketed Predicate Device(s): Standard Bariatrics Standard Clamp – K153358 Aesculap Inc. Manual Laparoscopic Instruments – K944467 Device Description: The Standa… | 2016 |
| * | K944467 | Aesculap Manual Laparoscopic InstrumentsSummary page 4…Marketed Predicate Device(s): Standard Bariatrics Standard Clamp – K153358 Aesculap Inc. Manual Laparoscopic Instruments – K944467 Device Description: The Standard Clamp is a reusable, non-energized, stainless steel surgical instrument designed for use in lap… | 1994 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170379 | Disposable Standard Clamp | 2017 | 1 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K170379 (Standard Bariatrics, 2017) has gone furthest, with 1 descendant 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. 2016, this device’s year, is highlighted.
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?
The Standard Clamp is indicated for use in laparoscopic procedures to grasp, clamp, and manipulate soft tissues.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161720 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161720: Standard Clamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161720
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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