510(k) · Cleared
ClearedAmr Mini-Laparoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical Resources · HET Laparoscope, Gynecologic (And Accessories)
Cleared on Aug 6, 1997 after a 385-day review. The FDA summary names its predicate without a number.
- Decided
- Aug 6, 1997
- Review
- 385 days
- Class
- Class II
- Product code
- HET
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 HET? 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 HET device
- #1 K250939 SIRIUS Endoscope System (PR-SI-1230)score 12.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | — | MICROLAP™ 2mm LAPAROSCOPE and INTRODUCER Named without a submission number | |
| † | K901214 | Rigid Ureteroscope | 1990 |
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.
How does its category compare?
All HET devicesHET Laparoscope, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HET
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HET
269in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HET
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HET
4,513in 2025
MAUDE reports naming product code HET, 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 | 0 | — | 0 | 181 |
| 2008 | 3 | 176 | 4 | 359 |
| 2009 | 1 | — | 1 | 403 |
| 2010 | 1 | — | 0 | 214 |
| 2011 | 2 | — | 0 | 417 |
| 2012 | 2 | — | 0 | 1,118 |
| 2013 | 2 | — | 0 | 1,035 |
| 2014 | 0 | — | 0 | 175 |
| 2015 | 2 | — | 1 | 124 |
| 2016 | 0 | — | 0 | 205 |
| 2017 | 2 | — | 0 | 89 |
| 2018 | 1 | — | 0 | 53 |
| 2019 | 2 | — | 0 | 44 |
| 2020 | 2 | — | 0 | 49 |
| 2021 | 4 | 269 | 0 | 132 |
| 2022 | 1 | — | 1 | 216 |
| 2023 | 0 | — | 4 | 824 |
| 2024 | 0 | — | 0 | 3,496 |
| 2025 | 2 | — | 0 | 4,513 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AMR Mini-Laparoscope is indicated for visualization and accessing the abdomen during laparoscopic procedures such as (but not limited to): Unexplained pelvic pain Infertility Work-up Tubal sterilization Diagnosis and/or treatment of ectopic pregnancy Evaluation, diagnosis and/or treatment of pelvic tumors, including myomata (less than 16 weeks gestational size.) Evaluation of congenital anomalies of the pelvic organs Retrieval of foreign bodies…
Read the full statement (102 words)
The AMR Mini-Laparoscope is indicated for visualization and accessing the abdomen during laparoscopic procedures such as (but not limited to):
Unexplained pelvic pain
Infertility Work-up
Tubal sterilization
Diagnosis and/or treatment of ectopic pregnancy
Evaluation, diagnosis and/or treatment of pelvic tumors, including myomata (less than 16 weeks gestational size.)
Evaluation of congenital anomalies of the pelvic organs
Retrieval of foreign bodies
Determination of the presence and extent of pelvic endometriosis
Determination of the presence and extent of pelvic inflammatory disease (if not in acute stage)
Access to abdomen for surgical procedures such as LAVH
Visualization, diagnosis and/or treatment of perforate abdominal (pelvic) organs.
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/K962777 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962777: Amr Mini-Laparoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962777
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026