Cleared Traditional

K140907 - LEECH, MEDICINAL (FDA 510(k) Clearance)

K140907 · Carolina Biological Supply Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
486d
Days
-
Risk

K140907 is an FDA 510(k) clearance for the LEECH, MEDICINAL. Classified as Leeches, Medicinal (product code NRN).

Submitted by Carolina Biological Supply Co. (Burlington, US). The FDA issued a Cleared decision on August 7, 2015 after a review of 486 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Carolina Biological Supply Co. devices

Submission Details

510(k) Number K140907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2014
Decision Date August 07, 2015
Days to Decision 486 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
372d slower than avg
Panel avg: 114d · This submission: 486d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NRN Leeches, Medicinal
Device Class -
Definition The Device Is A Medicinal Leech (hirudo Medicinalis) Belonging To The Annelida Worm Classification. The Animal Is A Bloodsucking Aquatic Animal Living In Fresh Water. The Device Should Be Indicated As: "an Adjunct To The Graft Tissue Healing When Problems Of Venous Congestion May Delay Healing, Or To Overcome The Problem Of Venous Congestion By Creating Prolonged Localized Bleeding." See Federal Register Notice At 89 Fr 106521 “transfer Of Regulatory Responsibility From The Center For Devices And Radiological Health To The Center For Biologics Evaluation And Research; Medical Maggots And Medicinal Leeches” (frn) (fda-2024-n-5702)