510(k) Report

510(k) · Cleared

Cleared

Autolap System

K152848510(k) TraditionalCleared Nov 17, 201549-day reviewClass II21 CFR 876.1500

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

M.S.T Medical Surgery Technologies, Ltd. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Nov 17, 2015 as substantially equivalent to K131375 (Mst - Medical Surgery Technologies, Ltd., 2013) after a 49-day review. Its family tree reaches back 6 generations to 1993. 2 later devices descend from it.

Decided
Nov 17, 2015
Review
49 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
1

Its longest line of descent runs back 6 generations to K931783 (1993). 2 later devices descend from it, 1 citing it directly.

  1. Root · 6 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
  2. 5 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
  3. 4 generations backK963126 Aesop System and AccessoriesComputer Motion, Inc. · 1997
  4. 3 generations backK972699 Aesop 3000 System and AccessoriesComputer Motion, Inc. · 1997
  5. 2 generations backK062968 Lapman Laparoscope Manipulator and Accessories, Model 900-200 SeriesMedsys, S.A. · 2007
  6. 1 generation backK131375 Autolap SystemMst - Medical Surgery Technologies, Ltd. · 2013
  7. This deviceK152848 Autolap SystemM.S.T Medical Surgery Technologies, Ltd. · 2015
  8. Descendant · cites it directly · 1 of its ownK242323 Maestro System (REF100)Moon Surgical · 2025
  9. Descendant · 2 generations on · 0 of its ownK250984 Maestro System (REF100)Moon Surgical · 2025

Most influential descendants

Showing 2 of 2 · See all
  • K242323Maestro System (REF100)Moon Surgical · 2025 · cites it directly1descendant
  • K250984Maestro System (REF100)Moon Surgical · 2025 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K931783Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc.1993—
−5K960655Aesop System and AccessoriesComputer Motion, Inc.1996—
−4K963126Aesop System and AccessoriesComputer Motion, Inc.1997—
−3K972699Aesop 3000 System and AccessoriesComputer Motion, Inc.1997—
−2K062968Lapman Laparoscope Manipulator and Accessories, Model 900-200 SeriesMedsys, S.A.2007—
−1K131375Autolap SystemMst - Medical Surgery Technologies, Ltd.2013—
0 (this device)K152848Autolap SystemM.S.T Medical Surgery Technologies, Ltd.2015—
+1K242323Maestro System (REF100)Moon Surgical2025—
+2K250984Maestro System (REF100)Moon Surgical2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202520
FIG. 1 — Lineage of K152848, 1993–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K131375Autolap System
Summary page 4
…ual Name Laparoscope Holder Classification Name Laparoscope, General and Plastic Surgery Predicate Devices AutoLap manufactured by M.S.T. Medical Surgery Technologies (K131375) Purpose of the 510(k) notice The AutoLap is a modification to the cleared AutoLap device. Indications for Use Statement The Au…
Mst - Medical Surgery Technologies, Ltd.2013—

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K242323Maestro System (REF100)Moon Surgical20251

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 22 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
  • None of the 6 ancestors has a recall.
  • Of its descendants, K242323 (Moon Surgical, 2025) has gone furthest, with 1 descendant of its own.

How does its category compare?

All GCJ devices

GCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · GCJ

21in 2025

2007: 182008: 192009: 212010: 242011: 152012: 172013: 152014: 192015: 262016: 272017: 202018: 212019: 152020: 282021: 182022: 202023: 312024: 292025: 212026 (partial year): 26
2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007: 42 days median2008: 73 days median2009: 85 days median2010: 122 days median2011: 113 days median2012: 88 days median2013: 93 days median2014: 90 days median2015: 76 days median2016: 99 days median2017: 77 days median2018: 88 days median2019: 60 days median2020: 61 days median2021: 116 days median2022: 103 days median2023: 109 days median2024: 90 days median2025: 108 days median2026 (partial year): 122 days median
2007high 122 (2010) · low 42 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GCJ

5in 2025

2007: 122008: 162009: 62010: 302011: 92012: 12013: 7, 1 Class I2014: 22016: 52017: 12018: 12022: 12023: 12025: 52026 (partial year): 1
2007high 30 (2010) · low 0 (2015)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GCJ

5,860in 2025

2007: 1,6392008: 1,3192009: 1,9952010: 2,6572011: 2,1332012: 1,5262013: 1,5652014: 1,7142015: 1,7102016: 2,0802017: 3,4682018: 2,5622019: 2,5782020: 2,6182021: 3,4312022: 3,9452023: 6,0022024: 6,0472025: 5,860
2007high 6,047 (2024) · low 1,319 (2008)2025

MAUDE reports naming product code GCJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071842121,639
20081973161,319
2009218561,995
201024122302,657
20111511392,133
2012178811,526
201315937 (1)1,565
2014199021,714
2015267601,710
2016279952,080
2017207713,468
2018218812,562
2019156002,578
2020286102,618
20211811603,431
20222010313,945
20233110916,002
2024299006,047
20252110855,860
2026261221—

What is it indicated for?

The AutoLap System is indicated for General laparoscopic, Gynecologic and Urologic procedures for the purpose of holding and controlling the movement of a standard laparoscope or rigid endoscope within surgical cavities during minimally invasive laparoscopic surgery.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K152848: Autolap System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K152848

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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