510(k) Report

510(k) · Cleared

Cleared

Magnetic Point Guard for Surgical Needles

K920706510(k) TraditionalCleared May 26, 1993463-day reviewClass I21 CFR 876.4730

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

Retrax · FHQ Holder, Needle, Gastroenterologic

Cleared on May 26, 1993 after a 463-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
May 26, 1993
Review
463 days
Class
Class I
Product code
FHQ
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K920706Source: FDA 510(k) database · 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FHQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

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 FHQ devices

FHQ Holder, Needle, Gastroenterologic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FHQ

FDA has decided no FHQ device since 2007.

Median 510(k) review, days · FHQ

Too few FHQ 510(k)s in any year since 2007 to give a median.

Recalls per year · FHQ

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FHQ

14in 2025

2007: 52008: 122009: 342010: 252011: 372012: 272013: 272014: 382015: 672016: 742017: 1012018: 1042019: 802020: 502021: 572022: 642023: 632024: 692025: 14
2007high 104 (2018) · low 5 (2007)2025

MAUDE reports naming product code FHQ, 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
20070—05
20080—012
20090—134
20100—025
20110—037
20120—027
20130—027
20140—038
20150—067
20160—074
20170—0101
20180—0104
20190—080
20200—050
20210—057
20220—064
20230—063
20240—069
20250—014
20260—0—

Recent decisions in FHQ

The FHQ category page

  • K974327Winged Needle HolderPhx Technologies Corp. · 1998
  • K924196Laparoscopic Needle HolderNusurg, Inc. · 1993
  • K930330Endoscopic Needleholder, ModificationHolmed Corp. · 1993
  • K85178025-230 to 25-390 Various Needle HoldersArtiberia · 1985
  • K85177925-100,25-220 Various Needle HoldersArtiberia · 1985

https://510kreport.com/device/K920706 · printed Nov 3, 2026

Cite this page

510(k) Report. “K920706: Magnetic Point Guard for Surgical Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K920706

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026