BRAVO PH MONITORING SYSTEM AND ACCESSORIES— 510(k) K102543
Substantially EquivalentGiven Imaging , Ltd.
FDA 510(k) clearance K102543 for BRAVO PH MONITORING SYSTEM AND ACCESSORIES, Substantially Equivalent on 2010-12-01. Applicant: Given Imaging , Ltd.. Device class: 1.
Clearance details
- Applicant
- Given Imaging , Ltd.
- Product code
- Code FFT
- Device class
- Class 1
- Regulation
- 21 CFR 876.1400
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Yoqneam, IL
Recent devices under product code FFT
view allMore clearances from Given Imaging , Ltd.
view allAdverse events under product code FFT
product code FFT- Injury
- 595
- Malfunction
- 2,175
- Other
- 1
- Total
- 2,771
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K102543
K-number listed on FDA's recall record- Z-2047-2025 — Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)
- Z-1334-2021 — CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age.
- Z-1335-2021 — BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102543.
Data sourced from openFDA. This site is unofficial and independent of the FDA.