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FDA 510(k)

SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000

K-Number: K950495 · 1995-05-09

ApplicantSurgical Dynamics, Inc.
Decision Date1995-05-09
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000 is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Dynamics, Inc.. It received FDA 510(k) clearance on 1995-05-09 under 510(k) number K950495. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000?

SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000 is a medical device that received FDA 510(k) clearance on 1995-05-09. The listed applicant is Surgical Dynamics, Inc.. The 510(k) number is K950495.

When did SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000 receive FDA 510(k) clearance?

SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000 received FDA 510(k) clearance on 1995-05-09, under 510(k) number K950495.

Who is the listed applicant for SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000?

The FDA 510(k) record lists Surgical Dynamics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000?

The FDA product code for SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000 is BTA.

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Other records listing Surgical Dynamics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K960046SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPEK942987NUCLEOTOME L KITK954193SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE & INSTRUMENT SETK931109NUCLEOTOME E KITK921950SURGICAL DYNAMICS DISCOGRAPHY SYSTEMK923525NUCLEOTOME 3.5 MM AUTOMATED PERCUTANEOUS LUMBAR

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Related Devices (Code: BTA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253629Momcozy Nasal Aspirator (BN007)Shenzhen Root Innovation Technology Co., Ltd.K260134Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)Shenzhen Root Innovation Technology Co., Ltd.K260892Suction Pump (SU-90)Shenzhen HugeMed Medical Technical Development Co., Ltd.K260473Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)Shenzhen Kingboom Technology Co., Ltd.K253107Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)Shenzhen Dongjiang Technology Co., Ltd.K260147Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)Shenzhen Kingboom Technology Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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