Cleared Special

Viveve System, Viveve 2.0 System (K212678) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K212678 · Viveve Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2021
Decision
21d
Days
Class 2
Risk

K212678 is an FDA 510(k) clearance for the Viveve System, Viveve 2.0 System. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Viveve Medical, Inc. (Englewood, US). The FDA issued a Cleared decision on September 14, 2021 after a review of 21 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Viveve Medical, Inc. devices

Submission Details

510(k) Number K212678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2021
Decision Date September 14, 2021
Days to Decision 21 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 115d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 694
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K212678.
Single Use Irrigation bipolar cable
K211170 · Modern Medical Equipment Manufacturing, Ltd. · Oct 2021
LAP-iX
K200639 · Sejong Medical Co., Ltd. · Sep 2021
POWERSEAL Curved Jaw Sealer and Divider, Double Action
K212643 · Olympus Surgical Technologies America · Sep 2021
CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)
K211579 · Bolder Surgical, LLC · Sep 2021
CellFX System
K211444 · Pulse Biosciences, Inc. · Aug 2021
Disposable Monopolar Laparoscopic Shafts and Reusable Handles
K210569 · Dannik, LLC · Aug 2021