Cleared Traditional

K092090 - ERBELIFT HAND PUMP AND FLEXIBLE PROBE

K092090 is an FDA 510(k) clearance for ERBELIFT HAND PUMP AND FLEXIBLE PROBE, manufactured by Byrne Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FBK cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K092090 · Byrne Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2009
Decision
139d
Days
Class 2
Risk

K092090 is an FDA 510(k) clearance for the ERBELIFT HAND PUMP AND FLEXIBLE PROBE. Classified as Endoscopic Injection Needle, Gastroenterology-urology (product code FBK), Class II - Special Controls.

Submitted by Byrne Medical, Inc. (Conroe, US). The FDA issued a Cleared decision on November 30, 2009 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Byrne Medical, Inc. devices

FDA 510(k) Submission Details - K092090

510(k) Number K092090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2009
Decision Date November 30, 2009
Days to Decision 139 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 131d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

FBK Device Classification - Class 2, Special Controls

Product Code FBK Endoscopic Injection Needle, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Inserted Through Endoscope For Injection Of A Solution, Gas, Or Implantable Materials Into Gi Or Gu Tissue.
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

Intertek Testing Services
DANIEL W LEHTONEN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FBK Endoscopic Injection Needle, Gastroenterology-urology

All 73
Devices cleared under the same product code (FBK) and FDA review panel - the closest regulatory comparables to K092090.
UROPLASTY RIGID ENDOSCPIC NEEDLES
K121337 · Uroplasty, Inc. · Aug 2012
INJEKT CYSTO FLEXIBLE INJECTION NEEDLE
K113634 · Cook Ireland, Ltd. · Feb 2012
COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K
K111495 · Wilson-Cook Medical, Inc. · Jul 2011
LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP
K090830 · Laborie Medical Technologies, Ltd. · Jul 2009
UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518
K091391 · Uroplasty, Inc. · Jun 2009
BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070
K090217 · Coloplast A/S · Apr 2009

FDA 510(k) Resources - Gastroenterology & Urology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.