# K974878: E3 Microprobe

- Pathway: 510(k) (Traditional)
- Applicant: Martin Uram, MD
- Decided: Mar 27, 1998 after 87 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) MicroProbe: named in the summary without a submission number
- (no number) Family of Endoscopes: named in the summary without a submission number
- (no number) Value Pack: named in the summary without a submission number
- (no number) Endoscope w. Cannula: named in the summary without a submission number
- (no number) Transtympanic Endoscope: named in the summary without a submission number
- (no number) Diomed (15, 30, 60) Surgical Diode Laser: named in the summary without a submission number
- (no number) Coherent Surgical Laser: named in the summary without a submission number
- (no number) ASI Uroplasty Cystoscope: named in the summary without a submission number
- (no number) Olympus Arthroscopy System: named in the summary without a submission number
- (no number) Olympus Laparo-Thoraco Videoscope: named in the summary without a submission number
- (no number) Olympus Oratracheal Intubation Endoscope: named in the summary without a submission number
- (no number) Olympus Endoscope System: named in the summary without a submission number
- (no number) Pentax Video Colonoscope: named in the summary without a submission number
- (no number) Pentex Video Duodenoscope: named in the summary without a submission number
- (no number) Pentax Video Gastroscope: named in the summary without a submission number
- (no number) Pentax Video Sigmoidoscope: named in the summary without a submission number
- (no number) Pentax Bronchofiberscope: named in the summary without a submission number
- (no number) Storz Flexible Fiberscope: named in the summary without a submission number
- (no number) Storz Flexible Rhino-Pharyngo-Laryngo-Fiberscope: named in the summary without a submission number
- (no number) Storz Flexible Hysteroscope: named in the summary without a submission number
- (no number) Storz Hopkins Telescope: named in the summary without a submission number
- (no number) Stryker Arthroscopy System: named in the summary without a submission number
- (no number) Stryker Sinuscope: named in the summary without a submission number

## Indications for use
Contact and non-contact excision, hemostasis, incision and vaporization for the following soft tissue applications: General Surgery Otorhinolaryngology Ophthalmology / Oculoplastic Pulmonary / Thoracic Urology Dermatology / Plastic Surgery Gastroenterology Neurosurgery Gynecology Orthopedic

Source page: https://510kreport.com/device/K974878
Methodology: https://510kreport.com/methodology
