Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

23ga Multi-Flex™ Extendable Laser Probe, Quantel Connector

Model V6510E-23C · KATALYST SURGICAL LLC · DI 10840096211426

HQA — Unit, Cryotherapy, Ophthalmic · Class II · 21 CFR 886.4170

UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

12232019-01: 0 reports for this device; peer average 2/device2019-07: 0 reports for this device; peer average 1/device2019-08: 0 reports for this device; peer average 1/device2019-09: 0 reports for this device; peer average 1/device2020-08: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 1/device2021-03: 0 reports for this device; peer average 1/device2021-05: 0 reports for this device; peer average 1/device2021-06: 0 reports for this device; peer average 1/device2021-10: 0 reports for this device; peer average 1.5/device2021-11: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 3/device2023-01: 0 reports for this device; peer average 1/device01070809080903050610111201
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102
2019-0701
2019-0801
2019-0901
2020-0801
2020-0901
2021-0301
2021-0501
2021-0601
2021-1001.5
2021-1101
2021-1203
2023-0101
This device (reports/month)Average device in HQA (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K121187 — cites (transitively): K050807 (d1) — cited as predicate by K140362, K142830, K182646

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — KATALYST SURGICAL LLC

  • VAI 2017-08-07 Katalyst Surgical, LLC · 2 citations
  • VAI 2017-08-07 Katalyst Surgical, LLC · 2 citations
  • VAI 2016-03-15 Katalyst Surgical, LLC · 6 citations
  • VAI 2016-03-15 Katalyst Surgical, LLC · 6 citations