Cleared Traditional

K921885 - E1070 & E1080 SERIES REUSABLE LLETZ ELECTRODES (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K921885 · Valleylab, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
703d
Days
Class 2
Risk

K921885 is an FDA 510(k) clearance for the E1070 & E1080 SERIES REUSABLE LLETZ ELECTRODES. Classified as Heater, Perineal, Direct Contact (product code HGZ), Class II - Special Controls.

Submitted by Valleylab, Inc. (Boulder, US). The FDA issued a Cleared decision on March 25, 1994 after a review of 703 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5390 - the FDA obstetrics and gynecology device framework. 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 Obstetrics & Gynecology submissions.

View all Valleylab, Inc. devices

Submission Details

510(k) Number K921885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1992
Decision Date March 25, 1994
Days to Decision 703 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
543d slower than avg
Panel avg: 160d · This submission: 703d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HGZ Heater, Perineal, Direct Contact
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5390
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.