# K961222: Evron Gel

- Pathway: 510(k) (Traditional)
- Applicant: Pharmaceutical Innovations, Inc.
- Decided: Jun 26, 1996 after 90 days
- Product code: KMJ (Lubricant, Patient)
- Device class: 1
- Regulation: 21 CFR 880.6375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
36 later devices descend from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ULTRA/PHONIC Conductivity Gel and related products (NDC#36-1000-00): named in the summary without a submission number
- (no number) ULTRA/PHONIC SG Scanning Gel (NDC#36-1001-00): named in the summary without a submission number
- (no number) GAMMA Massage and Ultrasound Gel (NDC#36-1150-00): named in the summary without a submission number

## Most influential descendants
- K063715: Juniper Cooling Device Xtra (2007), 35 descendants of its own
- K072152: Juniper CLN1 Dermal Cooling Device (2007), 34 descendants of its own
- K080118: Zeltiq Aesthetics CLN1 Dermal Cooling Device (2008), 33 descendants of its own
- K090094: Zeltiq System (2009), 32 descendants of its own
- K120023: Zeltiq Coolsculpting (2012), 31 descendants of its own

## Indications for use
Submitter’s lubricant is substantially equivalent to, and has the same intended use as, other products in commercial distribution in the United States prior to May 28, 1976. The proposed change to the lubricant consists of expanding the indications for use to specifically include the facilitation of breast self-examination.

Source page: https://510kreport.com/device/K961222
Methodology: https://510kreport.com/methodology